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

Pfizer

Status: Completed

Conditions: Gram Negative Infections

Treatments: Drug: Ceftazidime-avibactam

Study type: Observational

Funder types: Industry

Identifiers

NCT04628572

X9001260

Details and patient eligibility

About

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.

Enrollment: 189 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

189 participants in 1 patient group

Cohort 1

Description:

Eligible adults who have been treated with ≥ 48 hours of ceftazidime-avibactam in routine practice

Treatment:

Drug: Ceftazidime-avibactam