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): 204

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
• Genders Eligible for Study: All

• 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	Time Frame
Percent treatment success of patients treated with ceftazidime-avibactam	At Day 7 from ceftazidime avibactam initiation
Percent treatment success of patients treated with ceftazidime-avibactam	At day 14/ End of treatment from Ceftazidime-avibactam initiation, whichever is earlier
Percent microbiological success among patients treated with ceftazidime-avibactam	At Day 7 from ceftazidime-avibactam initiation
Percent microbiological success among patients treated with ceftazidime-avibactam	At day 14/ end of the treatment from Ceftazidime- avibactam initiation, whichever is earlier
Number of patients with serious and non-serious AEs with explicit attribution to Ceftazidime avibactam	Upto 30 days post treatment completion with Ceftazidime- Avibactam, death or discharge; whatever is first

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of patients with different sources of infection for which ceftazidime-avibactam was used.	At baseline
Percentage of patients given ceftazidime avibactam for different indications	At baseline
Describe the dose of ceftazidime avibactam in mg	Till 14 days/ End of the treatment with Ceftazidime-avibactam , whichever is earlier
Describe the frequency of dosing for ceftazidime- avibactam in hours	Till 14 days/ End of the treatment with ceftazidime- avibactam, whichever is earlier
Describe the duration of treatment with Ceftazidime avibactam in days	Till 14 Days/ End of the treatment with Ceftazidime-Avibactam, whichever is earlier
Percentage of patients who have been administered various combination antibiotic regimens along with ceftazidime avibactam	Till 14 days/ end of treatment with Ceftazidime-avibactam, whichever is earlier
Describe any prior antimicrobial therapy administered in the 90 days prior to current admission	At baseline
Describe the gram negative organisms identified and the susceptibility to ceftazidime -avibactam along with molecular typing	At baseline
Describe the in-hospital length of stay (LOS) in days in patients with infections treated by ceftazidime-avibactam	Up to 30 days post treatment completion with Ceftazidime- Avibactam death or discharge; whatever is first
Describe the length of stay in ICU in days in patients with infections treated by ceftazidime-avibactam	Up to 30 days post treatment completion with Ceftazidime- Avibactam death or discharge; whatever is first.
Percentage of various healthcare resource utilization in patients with infections treated by ceftazidime-avibactam	Up to 30 days post treatment completion with Ceftazidime- Avibactam death or discharge; whatever is first.
Determine the incidence of recurrent infections during the hospital stay, including re-infection and relapse	Up to 30 days post treatment completion with Ceftazidime- Avibactam, death or discharge; whatever is first.

Collaborators and Investigators

• Sponsor: 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): January 23, 2023
• Last Update Submitted That Met QC Criteria: January 20, 2023
• Last Verified: January 1, 2023

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; 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