- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07667582
Predictors and Outcomes of Ventilated Hospital-acquired Pneumonia
Hospital-acquired pneumonia (HAP) is defined as an infection of the pulmonary parenchyma that develops in patients admitted to hospital for more than 48 hours and that was not incubating at the time of admission. It represents one of the most common and serious nosocomial infections, associated with significant morbidity, prolonged hospitalisation, and increased mortality in critically ill patients.
The aetiology of HAP is primarily driven by micro-aspiration of bacteria colonising the oropharynx and upper gastrointestinal tract. Pathogen distribution is shaped by the duration of hospitalisation, prior antibiotic exposure, local epidemiology, and patient characteristics. Multidrug-resistant (MDR) organisms are particularly prevalent in patients with prolonged inpatient stay and intensive care unit (ICU) admission, as critically ill patients become rapidly colonised with nosocomial pathogens.
Ventilator-associated pneumonia (VAP), a subgroup of nosocomial pneumonia, occurs in patients requiring tracheal intubation and mechanical ventilation for at least 48 hours. A clinically important and increasingly recognised entity is ventilated HAP (v-HAP), defined as HAP that subsequently requires tracheal intubation and mechanical ventilation. Emerging evidence indicates that v-HAP carries the highest mortality among nosocomial pneumonia subtypes in ICU patients - exceeding VAP - while non-ventilated ICU-acquired HAP carries the lowest mortality.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
All subjects will be subjected to Complete history taking including demographic characteristics, diagnosis on admission to hospital, previous antibiotic treatment in the last 90 days, antibiotics upon which HAP developed, antibiotics described for HAP treatment, hospital stay before diagnosis of hospital-acquired pneumonia and before ICU admission, steroid use, inhalation antibiotic use, length of ICU stay, length of hospital stay, chronic underlying diseases,and APACHE II score. Vital signs, complete lab investigation sputum and blood cultures, Imaging, and arterial blood gases will be collected as soon as HAP diagnosis is settled and the following indices will be recorded
- CURB-65 and CRB-65 scores: The score is an acronym for each of the risk factors measured. Each risk factor scores one point, for a maximum score of 5: Confusion of new onset, Urea > 7 mmol/l (Blood Urea Nitrogen >19), Respiratory rate of 30 breaths per minute or greater, Blood pressure less than 90 mmHg systolic or diastolic blood pressure 60 mmHg or less and Age 65 or older [4].
- SMART-COP and SMRT-CO: The score is also an acronym for each of the risk factors measured; Systolic blood pressure (<90 mmHg, 2 points); Multilobar chest radiography involvement (1 point); low Albumin level (<3.5 g/dl, 1 point); high respiratory Rate (≤50 years: ≥25 br/min,>50 years: ≥30 br/min; 1 point); Tachycardia (≥125 bpm; 1 point); Confusion (new onset; 1 point); poor Oxygenation (≤50 years: PaO2 < 70 mmHg or O2 saturation ≤ 93%,>50 years: PaO2 <60 mmHg or O2 saturation <90%; 2 points); and low arterial PH (<7.35; 2 points)[5].
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Entsar Hsanen Mohamed, dr
- Phone Number: 01019968106
- Email: entsar.hsanen@aun.edu.eg
Study Locations
-
-
Asyut Governorate
-
Asyut, Asyut Governorate, Egypt, 71515
- Recruiting
- Assiut University Gospital
-
Contact:
- Entsar H Mohamed, DR
- Phone Number: 01019968106
- Email: entsar.hsanen@aun.edu.eg
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
- Adult patients (age ≥18 years) admitted to the Chest Department or Respiratory ICU, Assiut University Hospitals
- Diagnosis of HAP confirmed according to standard clinical, radiological, and microbiological criteria
- Hospital admission for more than 48 hours prior to pneumonia onset
- Ability to provide informed consent
Description
Inclusion Criteria:
All patients diagnosed with HAP in the chest department, Assiut University
Exclusion Criteria:
- Post operative patients
- Tracheostomized patients
- Comatosed patient since admission
- Suspected aspiration
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
HAP
Diagnosis of HAP confirmed according to standard clinical, radiological, and microbiological criteria
|
need for mechanical ventilation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Prevalence of mechanical ventilation among HAP patients (v-HAP rate).
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 1-Miron M., Blaj M., Ristescu A. I., et al. Hospital-Acquired Pneumonia and Ventilator-Associated Pneumonia: A Literature Review. Microorganisms 2024 , 12(1), 213. 2-Szychowiak P., Villageois-Tran K. The role of the microbiota in the management of intensive care patients. Annals of intensive care2022, 12(1), 3. 3-Howroyd F., Chacko C., MacDuff A., et al Ventilator-associated pneumonia: pathobiological heterogeneity and diagnostic challenges. Nature communications 2024, 15(1), 6447. 4-Bradley J, Sbaih N, Chandler TR, et al. Pneumonia Severity Index and CURB-65 Score Are Good Predictors of Mortality in Hospitalized Patients with SARS-CoV-2 Community-Acquired Pneumonia. Chest. 2022 Apr;161(4):927-936. 5-Al-Badawy T. H., Abouelela A. M., & Kawi, M. A. G. A. Predictive value of different scoring systems for critically ill patients with hospital-acquired pneumonia. Egyptian Journal of Chest Diseases and Tuberculosis 2016, 65(4), 757-763. 6-Metlay J. P., Waterer G. W., Long A. C., et al. Diagnosis and treatment of adults with community-acquired pneumonia. An official clinical practice guideline of the American Thoracic Society and Infectious Diseases Society of America. American journal of respiratory and critical care medicine 2019, 200(7), e45-e67. 7-Zhang S, Zhang K, Yu Y, et al. A new prediction model for assessing the clinical outcomes of ICU patients with community-acquired pneumonia: a decision tree analysis. Ann Med. 2019 Feb;51(1):41-50. 8-Reyes LF, Bastidas AR, Quintero ET,et al. Performance of the CORB (Confusion, Oxygenation, Respiratory Rate, and Blood Pressure) Scale for the Prediction of Clinical Outcomes in Pneumonia. Can Respir J. 2022 Jun 3;2022:4493777. 9-Brown SM, Dean NC. Defining and predicting severe community-acquired pneumonia. Curr Opin Infect Dis. 2010 Apr;23(2):158-64. 10-Kaya AE, Ozkan S, Usul E, et al. Comparison of pneumonia severity scores for patients diagnosed with pneumonia in emergency department. Indian J Med Res. 2020 Oct;152(4):
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Disease Attributes
- Respiratory Tract Infections
- Infections
- Respiratory Tract Diseases
- Lung Diseases
- Pneumonia
- Cross Infection
- Iatrogenic Disease
- Pathological Conditions, Signs and Symptoms
- Healthcare-Associated Pneumonia
- Therapeutics
- Airway Management
- Resuscitation
- Emergency Treatment
- Respiratory Therapy
- Respiration, Artificial
Other Study ID Numbers
- Predictors of ventilated HAP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hospital Acquired Pneumonia
-
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Not yet recruitingHospital-acquired Bacterial Pneumonia/Ventilator-associated Bacterial PneumoniaChina
-
Qilu Pharmaceutical Co., Ltd.RecruitingHospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial PneumoniaChina
-
Nanjing Yoko Biomedical Co., Ltd.Not yet recruitingHospital-acquired Bacterial Pneumonia (HABP) | Ventilator-associated Bacterial Pneumonia (VABP)
-
Assistance Publique - Hôpitaux de ParisRecruitingCommunity Acquired or Acquiring Hospital Acquired PneumoniaFrance
-
Fraser HealthOndine Biomedical Inc.; Royal Columbian Hospital FoundationCompletedHospital Acquired Pneumonia | Ventilator Acquired Pneumonia | Hospital Acquired Infections | Nasal Decolonization of Staphylococcus AureusCanada
-
Melinta Therapeutics, Inc.WithdrawnHospital-Acquired Bacterial Pneumonia | Ventilator-Associated Bacterial Pneumonia | Hospital-Acquired Pneumonia | Ventilator-Associated Pneumonia
-
Basilea PharmaceuticaCompletedCommunity-acquired Pneumonia (CAP) | Hospital-acquired Pneumonia (HAP)Bulgaria, Hungary, Georgia, Romania
-
Ruta NutautieneEnrolling by invitationHospital Acquired Pneumonia | Community Acquired Pneumonia (CAP)Lithuania
-
University Medical Centre LjubljanaUniversity of Ljubljana, Faculty of MedicineUnknownCommunity Acquired Pneumonia | Ventilator Associated Pneumonia | Hospital Acquired PneumoniaSlovenia
-
Liverpool University Hospitals NHS Foundation TrustLiverpool School of Tropical MedicineCompletedCommunity Acquired Pneumonia | Lower Respiratory Tract Infection | Hospital Acquired PneumoniaUnited Kingdom
Clinical Trials on mechanical ventilation (MV)
-
Ain Shams UniversityNot yet recruitingARDS | ARDS: Acute Respiratory Distress Syndrome
-
Daping Hospital and the Research Institute of Surgery...RecruitingARDS | RDS | SurfactantChina
-
Johns Hopkins UniversityTerminatedAcute Respiratory Distress Syndrome | Acute Lung Injury | Mechanical VentilationUnited States
-
Assiut UniversityNot yet recruitingPediatric Sepsis-induced Multiple Organ Dysfunction SyndromeEgypt
-
Torbat Heydariyeh University of Medical SciencesCompletedMedical Education | Nursing StudentsIran
-
Kocaeli City HospitalCompletedMechanical Ventilation | Mechanical Power | Laparoscopic Abdominal Surgery | Optimum PEEPTurkey (Türkiye)
-
Ruijin HospitalUnknownAcute Pancreatitis | Complication of Ventilation TherapyChina
-
Peking Union Medical College HospitalThe First Affiliated Hospital with Nanjing Medical University; National Natural... and other collaboratorsUnknownAcute Respiratory Failure | Immunocompromised Patients
-
Riphah International UniversityCompletedBurns (Physical Finding)Pakistan
-
Limin ZhuUnknownRight Ventricular Hypertrophy | Congenital Heart Disease | Postoperative Care | Mechanical Ventilation | Heart-lung InteractionChina