Retrospective Analysis of Real World Use of Ceftazidime-avibactam in the Management of Gram Negative Infections

Retrospective Analysis to Characterize the Real World Use Patterns, Efficacy and Safety of Ceftazidime-avibactam in the Management of Gram Negative Infections.

The main objective of this non-interventional (retrospective) study is to describe the general treatment patterns, effectiveness, and safety of ceftazidime-avibactam in real-world settings in India. Eligible patients would be adults who have been treated with ≥ 48 hours of ceftazidime-avibactam in routine practice from 01 June 2019 to 01 April 2020. Data of 500 patients will be collected through the abstraction of hospital medical records (electronic) if available or through the individual patient medical record in case electronic records are not available.

Study Overview

• Status: Completed
• Conditions: Gram Negative Infections
• Intervention / Treatment: Drug: Ceftazidime-avibactam

• Study Type: Observational
• Enrollment (Actual): 189

Contacts and Locations

Study Locations

• India
  • Bhandup West, India, 400078
    • Fortis Hospital
  • Chennai, India, 600006
    • Apollo Hospital
  • Chennai, India, 600100
    • Gleneagles Global Hospitals
  • Erandwane,, PUNE, India, 411004
    • Deenanath Mangeshkar Hospital and Research Centre
  • Hyderabad, India, HYDERABAD
    • Apollo Hospital
  • Noida, India, 201301
    • Metro Hospital
  • Pune, India, 411001
    • Grant Medical Foundation Ruby Hall Clinic
  • WEST Bengal, India, 700098
    • AMRI Hospital

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

Hospitalized patients with documented gram negative infection and treated with Ceftazidime-avibactam for atleast 48 hours.

Description

Inclusion Criteria:

1. more than or equal to 18 years of age
2. Admitted to hospital with documented gram negative infection
3. Has received treatment for atleast 48 hours (complete) with Ceftazidime-Avibactam as a part of his routine clinical management

Exclusion Criteria:

1. The patient is enrolled in any clinical trial of an investigational product
2. Age <18 years
3. Received Ceftazidime avibactam for less than 48 hours.
4. Patient with documented Acinetobacter infection.
5. Patient was a part of named access program or any other interventional study

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cohort 1; Eligible adults who have been treated with ≥ 48 hours of ceftazidime-avibactam in routine practice	Drug: Ceftazidime-avibactam; Non-Interventional Study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Clinical Symptom Improvement at Day 3	The clinical symptom improvement was assessed as per the clinical judgement of the physician and reported as symptom improved and symptom worsened.	Day 3 after ceftazidime-avibactam initiation
Number of Participants With Treatment Success at Day 7	The treatment success was defined as resolution of all signs and symptoms of the infection based on the clinician's judgment and the treatment protocol/algorithm followed at the respective centers. The treatment success in terms of clinical outcome was classified as clinical success (resolution of all signs and symptoms of the infection), clinical failure (persistence of signs and symptoms from baseline) and indeterminate (there is not enough information to conclude whether the antibiotic regimen containing ceftazidime-avibactam was a clinical failure or a success).	Day 7 after ceftazidime-avibactam initiation
Number of Participants With Treatment Success at Day 14 or End of Treatment	The treatment success was defined as resolution of all signs and symptoms of the infection based on the clinician's judgment and the treatment protocol/algorithm followed at the respective centers. The treatment success in terms of clinical outcome was classified as clinical success (resolution of all signs and symptoms of the infection), clinical failure (persistence of signs and symptoms from baseline) and indeterminate (there is not enough information to conclude whether the antibiotic regimen containing ceftazidime-avibactam was a clinical failure or a success).	Day 14 or End of Treatment after ceftazidime-avibactam initiation, whichever was earlier
Number of Participants With Microbiological Success at Day 7	Microbiological success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication) and repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication).	Day 7 after ceftazidime-avibactam initiation
Number of Participants With Microbiological Success at Day 14 or End of Treatment	Microbiological success was defined as absence of causative pathogen from appropriately obtained specimens at the site of infection (eradication) and repeat cultures were not performed/clinically indicated in a participant who had a clinical response of cure (presumed eradication).	Day 14 or End of Treatment after ceftazidime-avibactam initiation, whichever was earlier
Number of Participants With Serious Adverse Events and Non-Serious Adverse Events With Explicit Attribution to Ceftazidime-Avibactam	An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that: resulted in death, was life threatening (immediate risk of death), required hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions), resulted in congenital anomaly/birth defect. All AEs that did not meet the criteria for "serious" were considered as non-serious. Adverse events with explicit attribution to any Pfizer drug that appeared in the reviewed information (defined per the participant population and study period specified in the protocol) were reported. Explicit attribution was not inferred by temporal relationship between drug administration and an AE, but was based on a causality assessed by a healthcare provider linking drug administration and AE.	Up to 30 days post treatment completion with ceftazidime-avibactam, death or discharge; whichever was first (Up to maximum of 49 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Classified According to Source of Infection at Baseline for Which Ceftazidime-Avibactam Was Used	Source of infection included hospital-acquired infection, healthcare-associated infection, and community-acquired infection.	Baseline (before initiation of initial antibiotic therapy)
Number of Participants According to Indication at Baseline for Which Ceftazidime-Avibactam Was Used	The indications for use of ceftazidime-avibactam at baseline including urinary tract infection, intra-abdominal infection and nosocomial pneumonia and any other indication were reported.	Baseline (before the initiation of initial antibiotic therapy)
Dose of Ceftazidime - Avibactam	In this outcome measure dose (median of daily dose) of ceftazidime-avibactam was reported till Day 14 or End of treatment whichever was earlier.	Up to Day 14 or End of treatment after ceftazidime-avibactam initiation, whichever was earlier
Number of Participants According to Frequency of Administration	Number of participants according to frequency of administration (twice daily [BID], once daily [OD] and thrice daily [TID]) of ceftazidime-avibactam is reported in this outcome measure.	Up to Day 14 or End of treatment after ceftazidime-avibactam initiation, whichever was earlier
Duration of Administration of Ceftazidime - Avibactam		Up to Day 14 or End of treatment after ceftazidime-avibactam initiation, whichever was earlier
Total Duration of Therapy of Ceftazidime-Avibactam		Up to Day 14 or End of treatment after ceftazidime-avibactam initiation, whichever was earlier
Number of Participants Who Received Concomitant Antibiotics With Ceftazidime-Avibactam		Up to Day 14 or End of treatment after ceftazidime-avibactam initiation, whichever was earlier
Number of Participants With History of Antibiotic Exposure		90 days prior to current hospital admission
Number of Participants According to Identified Gram Negative Organisms	In this outcome measure, the gram-negative organisms identified at baseline was reported. One participant could have more than one gram-negative bacteria identified.	Baseline (before the initiation of initial antibiotic therapy)
Number of Participants With Identified Pathogens Susceptible to Ceftazidime-Avibactam		Baseline (before the initiation of initial antibiotic therapy)
Duration of Hospital Stay	Duration of hospital stay was calculated based on 1) total number of consecutive days the participant was treated in the hospital from admission to discharge during their initial hospitalization; 2) the total number of days of hospitalization between diagnosis of infection and discharge; 3) the total number of days the participant was treated in the hospital after ceftazidime-avibactam initiation up to hospital discharge, including the first day of treatment.	Up to 30 days post treatment completion, death or discharge; whichever was first (Up to maximum of 49 days)
Duration of Stay in Intensive Care Unit (ICU)	Intensive care unit length of stay was calculated based on 1) the total number of consecutive or non-consecutive days the participant was treated in the ICU during their initial hospitalization; and 2) the total number of days the participant was treated in the ICU after ceftazidime-avibactam initiation, including the first day of treatment.	Up to 30 days post treatment completion, death or discharge; whichever was first (Up to maximum of 49 days)
Number of Participants According to Healthcare Resource Utilization	In this outcome measure number of participants were reported as per their healthcare resource utilization data, abstracted from the participant medical records. Healthcare resources included: mechanical ventilation, computed tomography (CT)/magnetic resonance imaging (MRI), tracheostomy, hemodialysis, surgical intervention, percutaneous procedures and other procedures.	Up to 30 days post treatment completion with ceftazidime-avibactam death or discharge; whichever was first (Up to maximum of 49 days)
Number of Participants With Recurrence of Infection	Number of participants with recurrence of infection during hospital stay, including re-infection and relapse up to 30 days post treatment completion with ceftazidime-avibactam, death or discharge; whichever occurred first was summarized in this outcome measure.	Up to 30 days post treatment completion with ceftazidime-avibactam, death or discharge; whichever was first (Up to maximum of 49 days)

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): January 29, 2021
• Primary Completion (Actual): March 11, 2022
• Study Completion (Actual): March 11, 2022

Study Registration Dates

• First Submitted: October 7, 2020
• First Submitted That Met QC Criteria: November 12, 2020
• First Posted (Actual): November 13, 2020

Study Record Updates

• Last Update Posted (Actual): August 14, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; beta-Lactamase Inhibitors; Third Generation Cephalosporins; Beta Lactam Antibiotics; Avibactam; Ceftazidime; Avibactam, ceftazidime drug combination
• Other Study ID Numbers: X9001260

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