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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

189 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-29

Study Completion Date

2022-03-11

Brief Summary

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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.

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Detailed Description

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Conditions

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Gram Negative Infections

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Cohort 1

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

Ceftazidime-avibactam

Intervention Type DRUG

Non-Interventional Study

Interventions

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Ceftazidime-avibactam

Non-Interventional Study

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No