Retrospective Chart Review Study to Assess Characteristics, Treatment Outcomes and Resource Use of Adults Hospitalized for CAP and CSSTi Treated With Zinforo in Multiple Countries

MULTINATIONAL Retrospective Chart Review Study to Assess the Characteristics, Treatment Outcomes and Resource Use Among Adult Patients Hospitalised for Community-Acquired Pneumonia (CAP) or Complicated Skin and Soft Tissue Infections (cSSTI) Treated With Zinforo (REGISTERED) (Ceftaroline Fosamil) in a Usual Care Setting

MULTINATIONAL Retrospective Chart Review Study to Assess the Characteristics, Treatment Outcomes and Resource Use Among Adult Patients Hospitalized for Community-Acquired Pneumonia (CAP) or Complicated Skin and Soft Tissue Infections (cSSTI) Treated with Zinforo® (ceftaroline fosamil) in a Usual Care Setting

Study Overview

• Status: Completed
• Conditions: Community Acquired Pneumonia; Complicated Skin and Soft Tissue Infection
• Intervention / Treatment: Drug: Zinforo (ceftaroline fosamil)

Detailed Description

The overall study aim is to provide real world evidence (RWE) on the characteristics, clinical management, treatment outcomes and healthcare resource use of adult patients aged 18 years and older admitted to the hospital for CAP or cSSTI who received Zinforo® in a usual care setting in Europe and Latin America on or before 31-May-2019.

• Study Type: Observational
• Enrollment (Actual): 317

Contacts and Locations

Study Locations

• Brazil
  • Recife, Brazil, 50070-480
    • Hospital Esperança
  • PE
    • Recife, PE, Brazil, 52010-075
      • Real Hospital Portugues de Beneficencia
• Colombia
  • Cali, Colombia
    • Centro Médico Imbanaco
  • Antioquia
    • Medellin, Antioquia, Colombia, 50025
      • Clínica Las Américas
  • Risaralda
    • Pereira, Risaralda, Colombia, 660002
      • E.S.E. Hospital Universitario San Jorge de Pereira
  • Valle DEL Cauca
    • Cali, Valle DEL Cauca, Colombia, 760032
      • Fundación Valle del Lili
• France
  • Dijon, France, 21000
    • CHU François Mitterrand
  • Grenoble, France, 38700
    • CHU de Grenoble Alpes
  • Lyon, France, 69004
    • Croix-Rousse Hospital, Hospices Civils de Lyon
  • Nantes, France, 44093
    • CHU Nantes
• Greece
  • Athens, Greece, 12462
    • Attikon University General Hospital
  • Heraklion, Greece, 71110
    • University Hospital of Heraklion
  • Larissa, Greece, 41110
    • General University Hospital Of Larissa
  • Patras, Greece, 26504
    • Patras University Medical School
  • Thessaloniki, Greece, 54621
    • AHEPA General University Hospital of Thessaloniki
• Italy
  • Napoli, Italy, 80131
    • Azienda Ospedaliera Dei Colli
  • Turin, Italy, 10141
    • Aou Citta Della Salute E Della Scienza Scdu Malattie Infettive 2
  • Udine, Italy, 33100
    • Azienda Sanitaria Universitaria Friuli Centrale (ASU FC), Presidio Ospedaliero Universitario Santa
  • Other
    • Brescia, Other, Italy, 25123
      • Asst Spedali Civili Brescia and Universita Degli Studi di Brescia
    • Napoli, Other, Italy, 80131
      • AORN Ospedali dei Colli - Ospedale Monaldi
• Russian Federation
  • Republic OF Bashkortostan
    • Ufa, Republic OF Bashkortostan, Russian Federation, 450005
      • Republican Clinical Hospital named after G.G. Kuvatova
  • Udmurtia
    • Izhevsk, Udmurtia, Russian Federation, 426039
      • BUZ UR First Republican Clinical Hospital under the Ministry of Healthcare of Udmurt Republic UR
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic
  • Barcelona, Spain, 8035
    • Hospital Universitario Valle de Hebron
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28034
    • Hospital Ramon y Cajal

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The target population is adult patients aged 18 years and older hospitalized for CAP or cSSTI who received intravenous (IV) Zinforo® treatment in a usual care setting in Europe and Latin America on or before 31-May-2019.

Description

Inclusion criteria:

1. Age 18 years or older at admission date to the hospital;
2. Received four (4) or more consecutive IV doses of Zinforo® in usual care on or before 31-May-2019; and
3. Admitting diagnosis to the hospital was either CAP or cSSTI.

Exclusion criteria:

1. Patients who were participating in an interventional clinical trial during the same hospital admission in which Zinforo® was administered;
2. Patients whose hospital medical records are missing documentation of the diagnostic criteria for either cSSTI or CAP;
3. Patients whose hospital medical records are missing details of dosing with Zinforo®;
4. Patients whose hospital medical records are missing information on the success/failure of Zinforo® treatment and the reason why treatment was discontinued; and
5. Patients whose hospital medical records are missing discharge date and status information.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Zinforo Treated; Only those Adults treated with this treatment for CAP or cSSTi	Drug: Zinforo (ceftaroline fosamil); IV Solution; Other Names: Teflaro

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Clinical Response	Clinical response in CAP was defined as participants demonstrating clinical stability (i.e., according to the Infectious Disease Society of America [IDSA] guidelines a temperature of less than or equal to (<=) 37.8 degree Celsius, heart rate of <=100 beats per minute, respiratory rate of <=24 breaths per minute, systolic blood pressure of greater than or equal to (>=) 90 millimeters of mercury (mmHg), oxygen saturation of >=90%, and confusion/disorientation recorded as absent) and clinical improvement (i.e., improvement of at least 1 of 4 symptoms present at Baseline [i.e., cough, dyspnea, pleuritic chest pain, sputum production] with worsening of none). Clinical response in cSSTI participants was defined as >=20% reduction from baseline infection area and cessation of spread measured by total infection area.	Day 1 of Zinforo treatment till end of Zinforo treatment: up to maximum of 35 days for CAP; up to maximum of 60 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Time to Clinical Response	Clinical response in CAP was defined as participants demonstrating clinical stability (i.e., according to the IDSA guidelines a temperature of <=37.8 degree Celsius, heart rate of <=100 beats per minute, respiratory rate of <=24 breaths per minute, systolic blood pressure of >=90 mmHg, oxygen saturation of >=90%, and confusion/disorientation recorded as absent) and clinical improvement (i.e., improvement of at least 1 of 4 symptoms present at Baseline (i.e., cough, dyspnea, pleuritic chest pain, sputum production) with worsening of none). Clinical response in cSSTI participants was defined as >=20% reduction from baseline infection area and cessation of spread measured by total infection area.	Day 1 of Zinforo treatment till end of Zinforo treatment: up to maximum of 35 days for CAP; up to maximum of 60 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Number of Participants Who Achieved Clinical Cure	Clinical cure for both CAP and cSSTI was defined as the resolution of clinical features or improvement status requiring no further antibiotic therapy. Participants who achieved clinical cure were reported in this outcome measure.	Day 1 of Zinforo treatment till end of Zinforo treatment: up to maximum of 35 days for CAP; up to maximum of 60 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Time to Clinical Cure	Clinical cure for both CAP and cSSTI was defined as the resolution of clinical features or improvement status requiring no further antibiotic therapy. Time taken to achieve the clinical cure was reported in this outcome measure.	Day 1 of Zinforo treatment till end of Zinforo treatment: up to maximum of 35 days for CAP; up to maximum of 60 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Number of Participants With Clinical Failure	Clinical failure for both CAP and cSSTI was defined as any of the following: treatment modification due to adverse event (AE); drug-drug interaction; insufficient response (followed by switch); death due to index infection; death due to other cause; relapse or recurrence.	Day 1 of Zinforo treatment till end of Zinforo treatment: up to maximum of 35 days for CAP; up to maximum of 60 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
CAP: Number of Participants According to Reasons for Clinical Failure	Clinical failure was defined as any of the following: treatment modification due to AE; drug-drug interaction; insufficient response (followed by switch); death due to index infection; death due to other cause; relapse or recurrence. Number of participants with CAP, according to the reasons for their clinical failure were reported in this outcome measure. Only those reasons which had at least 1 participant has been reported.	Day 1 of Zinforo treatment till end of Zinforo treatment, up to maximum of 35 days (from the retrospective data evaluated in approximately 14 months of the study)
cSSTI: Number of Participants According to Reasons for Clinical Failure	Clinical failure was defined as any of the following: treatment modification due to AE; drug-drug interaction; insufficient response (followed by switch); death due to index infection; death due to other cause; relapse or recurrence. Number of participants with cSSTI, according to the reasons for their clinical failure were reported in this outcome measure. Only those reasons which had at least 1 participant has been reported.	Day 1 of Zinforo treatment till end of Zinforo treatment, up to maximum of 60 days (from the retrospective data evaluated in approximately 14 months of the study)
CAP Only: Time to Clinical Stability	Clinical stability was defined according to the IDSA guidelines as temperature of <=37.8 degree Celsius, heart rate of <=100 beats per minute, respiratory rate of <=24 breaths per minute, systolic blood pressure of >=90 mmHg, oxygen saturation of >=90%, and confusion/disorientation recorded as absent. The time to achieve clinical stability was reported in this outcome measure.	Day 1 of Zinforo treatment till end of Zinforo treatment, up to maximum of 35 days (from the retrospective data evaluated in approximately 14 months of the study)
CAP Only: Time to Clinical Improvement	Clinical improvement was defined as improvement of at least 1 of 4 symptoms present at Baseline (i.e., cough, dyspnea, pleuritic chest pain, sputum production) with worsening of none. The time to clinical improvement was reported in this outcome measure.	Baseline (before Day 1 of Zinforo treatment) till end of Zinforo treatment, up to maximum of 35 days [from the retrospective data evaluated in approximately 14 months of the study]
CAP: Number of Participants With Early Response Within 4 Days	Clinical response in CAP was defined as participants demonstrating clinical stability (i.e., according to the IDSA guidelines a temperature of <=37.8 degree Celsius, heart rate of <=100 beats per minute, respiratory rate of <=24 breaths per minute, systolic blood pressure of >=90 mmHg, oxygen saturation of >=90%, and confusion/disorientation recorded as absent) and clinical improvement (i.e., improvement of at least 1 of 4 symptoms present at Baseline [i.e., cough, dyspnea, pleuritic chest pain, sputum production] with worsening of none). Participants with CAP who showed response within 4 days after treatment with Zinforo were reported in this outcome measure.	Within 4 days after treatment with Zinforo (from the retrospective data evaluated in approximately 14 months of the study)
cSSTI: Number of Participants With Early Response Within 3 Days	Clinical response in cSSTI participants was defined as >=20% reduction from baseline infection area and cessation of spread measured by total infection area. Participants with cSSTI who showed response within 3 days after treatment with Zinforo were reported in this outcome measure.	Within 3 days after treatment with Zinforo (from the retrospective data evaluated in approximately 14 months of the study)
cSSTI Only: Time to Greater Than or Equal to (>=) 20% Reduction From Baseline in Infection Area	The response to treatment in cSSTI participants was measured as >=20% reduction from baseline in infection area.	Baseline (before Day 1 of treatment) till end of treatment, up to maximum of 60 days [from the retrospective data evaluated in approximately 14 months of the study]
cSSTI Only: Time to Cessation of Spread Measured by Total Infection Area	The response to treatment in cSSTI participants was measured as cessation of spread of infection measured by total infection area.	Day 1 of Zinforo treatment till end of Zinforo treatment, up to maximum of 60 days (from the retrospective data evaluated in approximately 14 months of the study)
cSSTI Only: Time to Cessation of Spread Measured by Infection Length and Width	Time taken for the cessation of spread of infection as measured by length and width of the infected area was reported in this outcome measure.	Day 1 of Zinforo treatment till end of Zinforo treatment, up to maximum of 60 days (from the retrospective data evaluated in approximately 14 months of the study)
Number of Participants According to Discharge Status	Participants were categorized based on the discharge status in this outcome measure.	At discharge from hospital: any day till 102 days for CAP; any day till 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Number of Participants With Re-hospitalization Within 30 Days of Discharge	The number of participants who were re-hospitalized within 30 days of discharge were reported in this outcome measure.	Within 30 days after discharge from hospital (discharge was any day till 102 days for CAP; any day till 162 days for cSSTI) [from the retrospective data evaluated in approximately 14 months of the study]
Number of Participants According to Vital Status Within 30 Days of Discharge	The number of participants were classified according to the vital status in this outcome measure.	Within 30 days after discharge from hospital (discharge was any day till 102 days for CAP; any day till 162 days for cSSTI) [from the retrospective data evaluated in approximately 14 months of the study]
Number of Participants According to Minimum Inhibitory Concentration (MIC) Assessment	MIC was defined as the lowest concentration of an antimicrobial that will inhibit the visible growth of a microorganism. Participants were categorized as Yes, No or Unknown against being assessed for MIC.	From 1 week before Zinforo treatment through 24 hours post discontinuation of Zinforo treatment during index hospitalization (102 days for CAP; 162 days for cSSTI) [from retrospective data evaluated in approximately 14 months of study]
Day of MIC Assessment Since Index Hospitalization	Day of MIC assessment since the index hospitalization was reported in this outcome measure. Index hospitalization was first hospitalization on or before May 31, 2019 where Zinforo was administered for the treatment of CAP or cSSTI.	From Day 1 of Index hospitalization till MIC assessment, any day till 102 days for CAP; any day till 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Number of Participants According to MIC of Antibacterial Drugs Assessed Based on Pathogens	Pathogens for bacterial pneumonia were identified by blood, respiratory (e.g., sputum, bronchoalveolar lavage), or pleural effusion cultures and pathogens for cSSTI were identified blood or skin/soft tissue/bone/wound cultures. Number of participants with MIC of antibacterial drugs for pathogens isolated from samples were reported in this outcome measure.	From 1 week before Zinforo treatment through 24 hours post discontinuation of Zinforo treatment during index hospitalization (102 days for CAP; 162 days for cSSTI) [from retrospective data evaluated in approximately 14 months of study]
Number of Participants With Serious Adverse Events	An SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening; hospitalization/prolongation of hospitalization; persistent/significant disability/incapacity; congenital anomaly/birth defect; or that was considered as an important medical event.	Day 1 of Zinforo treatment till end of Zinforo treatment: up to maximum of 35 days for CAP; up to maximum of 60 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Number of Participants With Medical Conditions Presented at Index Hospitalization	The number of participants who had any medical conditions at the time of index hospitalization were reported in this outcome measure. Medical conditions that were considered included Human Immunodeficiency Virus (HIV) infection, alcohol abuse, cancer/malignancy, cerebrovascular disease, chronic dialysis within the past 30 days, chronic obstructive pulmonary disease, chronic renal disease, congestive heart failure, decompensated cirrhosis, diabetes mellitus, immunosuppressive disease, influenza, injection drug use, end stage liver disease, peripheral vascular disease, respiratory disease or any other relevant condition(s) or disease(s) that required chronic drug treatment. Index hospitalization was first hospitalization on or before May 31, 2019 where Zinforo was administered for the treatment of CAP or cSSTI.	At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)
Number of Participants With Hospitalization for Any Reason in the 3 Months Before the Index Hospitalization	The number of participants who had hospitalization for any reason, 3 months before the index hospitalization were reported in this outcome measure. Index hospitalization was first hospitalization on or before May 31, 2019 where Zinforo was administered for the treatment of CAP or cSSTI.	3 months prior to index hospitalization (from the retrospective data evaluated in approximately 14 months of the study)
Number of Participants With Invasive Major Surgical Treatment in the 3 Months Before the Index Hospitalization	The number of participants who had undergone surgical treatments, 3 months before to the index hospitalization were reported in this outcome measure.	3 months prior to index hospitalization (from the retrospective data evaluated in approximately 14 months of the study)
Number of Participants According to Therapies Received in the 3 Months Before the Index Hospitalization	Number of participants according to therapies received in the 3 months prior to index hospitalization were reported in this outcome measure. One participant could receive more than one therapy.	3 months prior to index hospitalization (from the retrospective data evaluated in approximately 14 months of the study)
Number of Participants With Radiographic Findings in Tests for CAP	Participants were categorized according to radiographic findings in the tests conducted for diagnosis of CAP infection in this outcome measure. One participant could have more than one radiographic finding.	At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)
CAP: Number of Participants With Triggering Signs and Symptoms at Index Hospitalization	Participants were categorized according to triggering signs and symptoms at CAP diagnosis and recorded at index hospital admission were reported in this outcome measure. The observed signs and symptoms were dyspnea, tachypnea, or hypoxemia (oxygen [O2] saturation < 90% on room air or partial pressure of oxygen (pO2) < 60 mmHg), Fever (>38 degree Celsius[C]oral; > 38.5 degree C rectally or tympanically) or hypothermia (< 35 degree C), White Blood Cell (WBC) count > 10,000 cells/cubic millimeter(mm³) or < 4,500 cells/mm³. One participant could have more than one signs or symptoms.	At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)
Number of Participants With Severe CAP	Number of participants diagnosed with severe CAP were reported in this outcome measure.	At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)
Number of Participants According to Type of Prognostic Scoring System Used to Assess CAP Severity	In this outcome measure participants were categorized according to type of assessment used to assess CAP severity. Pneumonia severity index (PSI)/PORT score was used to calculate the probability of morbidity and mortality among participants with CAP. The score was used to predict the need for hospitalization in people with pneumonia. CURB- 65 was used to measure the confusion, blood urea, respiratory rate, blood pressure for the participants aged greater than or equal to 65 years. Multiple criteria to assess the severity of CAP exist. In this study severity was first globally assessed asking if a (any) criterion for severity of CAP would apply. In subsequent questions the details on the exact methods of the severity assessment were then asked. This included the information about PORT score / PSI, CURB-65 and recurrency of CAP.	At index hospitalization admission(from the retrospective data evaluated in approximately 14 months of the study)
Time of CAP Diagnosis at Index Hospitalization	The time taken (in days) taken to diagnose CAP in the participants prior to index hospitalization were reported in this outcome measure and this data was recorded at index hospitalization admission.	At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)
Number of Participants With Recurrent CAP Infections at Index Hospitalization	The number of participants with recurrent CAP infections were reported in this outcome measure.	At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)
Number of Participants According to Microbiological CAP Diagnosis at Index Hospitalization	The number of participants were classified according to the various pathogens identified during CAP diagnosis in this outcome measure.	At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)
Number of Participants According to Type of Investigation Performed for Positive Microbiological CAP Diagnosis at Index Hospitalization	The number of participants were classified according to the type of investigations performed for the microbiological CAP diagnosis and were reported in this outcome measure.	At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)
CAP: Number of Participants With Polymerase Chain Reaction (PCR) Determination of H1N1 Influenza Virus at Index Hospitalization	In this outcome measure number of participants who had H1N1 Influenza virus determined using PCR were reported.	At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)
CAP: Number of Participants According to Influenza Vaccination Status During 12 Months Prior to Index Hospitalization	The number of participants according to the status of influenza vaccination were reported in this outcome measure, as vaccinated: Yes, No and Unknown.	12 months prior to index hospitalization (from the retrospective data evaluated in approximately 14 months of the study)
CAP: Number of Participants According to Pneumococcal Vaccination Status at Index Hospitalization	The number of participants according to the status of pneumococcal vaccination were reported in this outcome measure.	At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)
CAP: Number of Participants According to the Biomarkers Used for Monitoring Clinical Evolution at Index Hospitalization	The number of participants were classified according to the biomarkers used for monitoring the state of CAP in this outcome measure.	At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)
cSSTI: Number of Participants According to Type of Lesions Involved at Index Hospitalization	The number of participants classified according to the types of lesions involved in the cSSTI infection were reported in this outcome measure. One participant could have more than one type of lesion.	At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)
cSSTI: Number of Participants According to Type of Body Area Involved at Index Hospitalization	The number of participants were classified according to the body area involved in cSSTI are reported in this outcome measure. One participant could have more than one type of body area involvement.	At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)
cSSTI: Number of Participants According to Area of Extension of Skin Infection at Index Hospitalization	The number of participants were classified according to the extent of skin that was affected with the infection in this outcome measure.	At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)
cSSTI: Number of Participants According to Level of Infections at Index Hospitalization	The number of participants were classified according to the level of infections in this outcome measure.	At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)
cSSTI: Number of Participants According to Type of Anatomical Structures Affected at Index Hospitalization	The number of participants were classified according to the anatomical structures involved in the infections in this outcome measure.	At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)
Time of cSSTI Diagnosis at Index Hospitalization	The time taken (in days) taken to diagnose cSSTI in the participants prior to index hospitalization were reported in this outcome measure and this data was recorded at index hospitalization admission.	At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)
cSSTI: Number of Participants With Recurrent Infection at Index Hospitalization	The number of participants that had recurrent cSSTI infections were reported in this outcome measure.	At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)
cSSTI: Number of Participants With Triggering Signs and Symptoms at Index Hospitalization	The number of participants with triggering signs and symptoms during the cSSTI diagnosis were reported in this outcome measure. One participant could have more than one triggering signs and symptoms.	At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)
Number of Participants According to Systemic Signs of cSSTI at Index Hospitalization	The number of participants were classified according to the systemic signs observed Including temperature greater than (>) 30 degree Celsius, White blood cell count >10,000 cells per millimeter cube(/mm3) or <4,500/mm3 or immature neutrophils >10%, septic shock, organ dysfunction and none of the above mentioned were reported. One participant could have more than one systemic sign.	At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)
cSSTI: Number of Participants According to Type of Diagnostic Tests Conducted at Index Hospitalization	The number of participants classified according to the diagnostic tests conducted to diagnose cSSTI were reported in this outcome measure. One participant could have more than one type of diagnostic test.	At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)
cSSTI: Number of Participants According to Microbiologic Diagnosis at Index Hospitalization	Pathogens identified by blood or skin/soft tissue/bone/wound cultures were recorded for participants with cSSTI.	At index hospitalization admission (from the retrospective data evaluated in approximately 14 months of the study)
Number of Participants According to Class of Antibiotics Received Prior to Zinforo Treatment During Index Hospitalization	The number of participants were classified according to types of antibiotics that they received prior to Zinforo and reported in this outcome measure.	Before Zinforo treatment initiation during index hospitalization, index hospitalization was of 102 days for CAP; 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Number of Participants According to Lines of Pre-Zinforo Therapies During Index Hospitalization	The number of participants were classified according to the lines of therapy in this outcome measure.	Before Zinforo treatment initiation during index hospitalization, index hospitalization was of 102 days for CAP; 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Number of Participants According to Routes of Administration for Pre-Zinforo Treatment During Index Hospitalization	The number of participants were classified according to various routes of administration for pre-Zinforo treatment and were reported in this outcome measure.	Before Zinforo treatment initiation during index hospitalization, index hospitalization was of 102 days for CAP; 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Duration of Pre-Zinforo Treatment During Index Hospitalization		Before Zinforo treatment initiation during index hospitalization, index hospitalization was of 102 days for CAP; 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Time From Symptom Onset to First Dose of Pre-Zinforo Treatment		Before Zinforo treatment initiation during index hospitalization, index hospitalization was of 102 days for CAP; 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Number of Participants According to Types of Pre-Zinforo Treatment During Index Hospitalization	The number of participants were classified according to types of Pre-Zinforo treatment and were reported in this outcome measure. One participant could have more than one type of pre-Zinforo treatment.	Before Zinforo treatment initiation during index hospitalization, index hospitalization was of 102 days for CAP; 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Number of Doses Administered for Pre-Zinforo Treatment During Index Hopsitalization		Before Zinforo treatment initiation during index hospitalization, index hospitalization was of 102 days for CAP; 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Number of Participants With Pre-Zinforo Treatment Modification During Index Hospitalization	The number of participants who had pre-Zinforo treatment modification were reported in this outcome measure.	Before Zinforo treatment initiation during index hospitalization, index hospitalization was of 102 days for CAP; 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Number of Participants According to Reasons for Pre-Zinforo Treatment Modification	The number of participants classified according to the reasons for pre-Zinforo treatment modification were reported in this outcome measure. One participant could have more than one reason for treatment modification. Index hospitalization was first hospitalization on or before May 31, 2019 where Zinforo was administered for the treatment of CAP or cSSTI. One participant could have more than one reason for treatment modification.	Before Zinforo treatment initiation during index hospitalization, index hospitalization was of 102 days for CAP; 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Number of Participants Based on Treatment Response to Pre-Zinforo Treatment During Index Hospitalization	Treatment response was defined according to the following criteria: CAP participants who demonstrated clinical stability (defined according to the Infectious Diseases Society of America [IDSA] guidelines as temperature of ≤37.8 C°, heart rate of ≤100 beats/min, respiratory rate of ≤24 breaths/min, systolic blood pressure of ≥90mmHg, oxygen saturation of ≥90%, and confusion/disorientation recorded as absent) and clinical improvement{defined as improvement of at least 1 of 4 symptoms present at baseline (i.e., cough, dyspnea, pleuritic chest pain, sputum production) with worsening of none}. cSSTI participants: ≥20% reduction from baseline infection area and cessation of spread measured by total infection area. The number of participants were classified according to treatment response to pre-Zinforo treatment and were reported in this outcome measure.	Before Zinforo treatment initiation during index hospitalization, index hospitalization was of 102 days for CAP; 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Time to Treatment Modification From Initial Dose of Pre-Zinforo Treatment	The time (days) taken for modification from initial dose of pre-Zinforo treatment were reported in this outcome measure.	Before Zinforo treatment initiation during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Number of Participants With Insufficient Response to Pre-Zinforo Treatment During Index Hospitalization	The number of participants with insufficient response to pre-Zinforo treatment were reported in this outcome measure.	Before Zinforo treatment initiation during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Duration of Zinforo Treatment During Index Hospitalization	The duration of Zinforo treatment for CAP and cSSTI infections were reported in this outcome measure.	Day 1 of Zinforo treatment till end of Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Time From Admission to First Dose of Zinforo During Index Hospitalization	The time taken from admission to the administration of first dose of Zinforo was reported in this outcome measure.	Day 1 of Zinforo treatment till end of Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Time From Symptom Onset to First Dose of Zinforo During Index Hospitalization	The time taken for the symptom onset to the administration of first dose of Zinforo was reported in this outcome measure.	During index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Number of Participants According to Types of Treatment for Zinforo	The number of participants classified according to the types of treatment for Zinforo were reported in this outcome measure. Types included empiric, definitive/specific and unknown. Empiric was defined as therapy administered to participants prior to the results of blood culture and susceptibility tests. Definitive was defined as therapy administered after the test results were received.	During index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Daily Dose of Zinforo		Day 1 of Zinforo treatment till end of Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Number of Infusions Administered Daily for Zinforo		Day 1 of Zinforo treatment till end of Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Number of Participants According to Locations of Zinforo Administration	The number of participants were classified according to the locations where Zinforo was administered were reported in this outcome measure. One participant could have more than one location of Zinforo administration.	Day 1 of Zinforo treatment till end of Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Number of Participants Administered Zinforo as Monotherapy or Combination Therapy	The number of participants were classified according to Zinforo administration as monotherapy or combination therapy were reported in this outcome measure.	Day 1 of Zinforo treatment till end of Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Number of Participants Receiving Concomitant Therapies Along With Zinforo	Number of participants who received concomitant therapies along with Zinforo were reported in this outcome measure.	Day 1 of Zinforo treatment till end of Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Number of Participants According to Type of Antibiotics Received for Index Infection After Zinforo Treatment	The number of participants were classified according to types of antibiotics received for index infection (CAP and cSSTI) after the Zinforo treatment were reported in this outcome measure. One participant could receive more than one type of antibiotic.	Post Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Number of Participants According to Lines of Therapy for Post-Zinforo Treatment	The number of participants were classified according to the lines of therapy for post-Zinforo treatment were reported in this outcome measure.	Post Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Number of Participants According to Route of Administration for Post-Zinforo Treatment	The number of participants were classified according to routes of administration for post-Zinforo treatment were reported in this outcome measure.	CAP (up to maximum of 102 days), cSSTI (up to maximum of 162 days)
Duration From Zinforo Discontinuation to Initiation of New Treatment	The duration in days from Zinforo treatment discontinuation to initiation of new treatment were reported in this outcome measure.	Post Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Number of Doses Administered for Post Zinforo Treatment		Post Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Number of Participants According to Reasons for Switching to Post-Zinforo Treatment	The number of participants were classified according to the reasons for switching to post-Zinforo treatment were reported in this outcome measure. One participant could have more than one reason for switch.	Post Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Number of Participants Based on Treatment Response to Post-Zinforo Treatment	Clinical response in CAP:participants demonstrating clinical stability(i.e.,according to IDSA guidelines:temperature of<=37.8 degree Celsius,heart rate of <=100 beats per minute,respiratory rate of <=24 breaths per minute,systolic blood pressure of >=90 mmHg,oxygen saturation of >=90%,confusion/disorientation recorded as absent),clinical improvement(i.e.,improvement of at least 1 of 4 symptoms present at Baseline(i.e.,cough,dyspnea,pleuritic chest pain,sputum production)with worsening of none).Clinical response in cSSTI participants:>=20% reduction from baseline infection area,cessation of spread measured by total infection area.Clinical failure for both CAP and cSSTI:any of the following:treatment modification due to AE;drug-drug interaction;insufficient response(followed by switch);death due to index infection;death due to other cause;relapse or recurrence. Number of participants classified according to treatment responses to post-Zinforo treatment reported in this outcome measure.	Post Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Number of Participant According to Type of Location for Post-Zinforo Treatment Administration	The number of participants were classified according to the locations in which post-Zinforo treatment was administered. One participant could have more than one location of administration.	Post Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Number of Participants Who Achieved Clinical Response to Post-Zinforo Treatment	Clinical response in CAP was defined as participants demonstrating clinical stability (i.e., according to the IDSA guidelines a temperature of <=37.8 degree Celsius, heart rate of <=100 beats per minute, respiratory rate of <=24 breaths per minute, systolic blood pressure of >=90 mmHg, oxygen saturation of >=90%, and confusion/disorientation recorded as absent) and clinical improvement (i.e., improvement of at least 1 of 4 symptoms present at Baseline (i.e., cough, dyspnea, pleuritic chest pain, sputum production) with worsening of none). Clinical response in cSSTI participants was defined as >=20% reduction from baseline infection area and cessation of spread measured by total infection area.	Post Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Number of Participants According to Reasons for Clinical Failure to Post-Zinforo Treatment	Clinical failure for both CAP and cSSTI was defined as any of the following: treatment modification due to AE; drug-drug interaction; insufficient response (followed by switch); death due to index infection; death due to other cause; relapse or recurrence. The number of participants were classified according to the reasons for clinical failure post-Zinforo treatment were reported in this outcome measure.	Post Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Duration of Index Hospitalization	Index hospitalization was first hospitalization on or before May 31, 2019 where Zinforo was administered for the treatment of CAP or cSSTI.	Day 1 of admission of index hospitalization to discharge from hospital (from the retrospective data evaluated in approximately 14 months of the study)
Duration in Intensive Care Unit		During index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Number of Participants Who Received Renal Replacement Therapy Post Initiating Treatment With Zinforo	The number of participants who received renal replacement therapy after initiating treatment with Zinforo were reported in this outcome measure.	Post initiation of Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Number of Participants According to Treatments Received During Index Hospitalization	The number of participants were classified according to treatments received during index hospitalization were reported in this outcome measure.	During index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Number of Participants Who Received Home-Based Care Through a Healthcare Agency	The number of participants who received home-based care through a healthcare agency were reported in this outcome measure.	Within 30 days post discharge from index hospitalization (from the retrospective data evaluated in approximately 14 months of the study)
Number of Participants With Re-hospitalizations	The number of participants who had re-hospitalizations were reported in this outcome measure.	Within 30 days post discharge from index hospitalization (from the retrospective data evaluated in approximately 14 months of the study)
Duration of Re-hospitalizations	In this outcome measure, data is recorded for duration (in days) of re-hospitalization (if any) that happened within 30 days post discharge from index hospitalization.	Day 1 of re-hospitalization till discharge (from the retrospective data evaluated in approximately 14 months of the study)
Number of Participants According to Reasons for Re-hozpitalization	The number of participants were classified according to reasons for re-hospitalizations were reported in this outcome measure. Re-hospitalization (if any) that happened within 30 days post discharge from index hospitalization.	Day 1 of re-hospitalization till discharge (from the retrospective data evaluated in approximately 14 months of the study)
Number of Participants With Development of Sepsis During Index Hospitalization	The number of participants who developed sepsis during index hospitalization were reported in this outcome measure.	During index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Number of Participants With Quick Sepsis-Related Organ Failure Assessment (qSOFA) Conducted	The qSOFA (also known as quickSOFA) was a bedside prompt that identified participants with suspected infection who are at greater risk for a poor outcome outside the intensive care unit (ICU). It used three criteria, assigning one point for low blood pressure Systolic blood pressure less than or equal to 100 millimeters of mercury (SBP<=100 mmHg), high respiratory rate greater than or equal to (>=) 22 breaths per min, or altered mentation (Glasgow coma scale<15).	During index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Number of Participants Requiring Isolation	The number of participants who required isolation were reported in this outcome measure.	During index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Number of Participants Who Received Mechanical Ventilation, Oxygen Therapy and Parenteral Nutrition		During index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Number of Participants Who Suffered Acute Renal Failure Necessitating Renal Replacement	The number of participants who suffered from acute renal failure and necessitated renal replacement were reported in this outcome measure.	During index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Total Number of Doses of Zinforo Administered		Day 1 of Zinforo treatment till end of Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Total Number of Doses of Other Antibiotics Administered in Combination With Zinforo		Day 1 of Zinforo treatment till end of Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Total Dose of Other Antibiotics Administered Post Zinforo Treatment		Post Zinforo treatment, during index hospitalization, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)
Cost of Hospitalization	The cost of hospitalization of standard level hospitals was calculated as total hospital cost= total number of bed days * per diem rate standard hospital general ward and the cost of hospitalization of advanced level hospitals was calculated as total number of bed days * per diem rate advanced hospital.	Day 1 of index hospitalization till discharge, index hospitalization was maximum of 102 days for CAP; maximum of 162 days for cSSTI (from the retrospective data evaluated in approximately 14 months of the study)

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): May 17, 2020
• Primary Completion (Actual): July 23, 2021
• Study Completion (Actual): August 30, 2021

Study Registration Dates

• First Submitted: November 5, 2019
• First Submitted That Met QC Criteria: December 12, 2019
• First Posted (Actual): December 13, 2019

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 25, 2024
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Bacteria; Zinforo® (ceftaroline fosamil); CAP; cSSTi; Hospitalized; Infectious Disease; Antibiotic; Cephalosporin
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Infections; Pneumonia; Soft Tissue Infections; Anti-Infective Agents; Anti-Bacterial Agents; Beta Lactam Antibiotics; Ceftaroline
• Other Study ID Numbers: C2661041

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No