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Clinical trial

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

ID
Name
X9001260
Description
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.
Trial arms
Trial start
2021-01-29
Estimated PCD
2022-03-11
Trial end
2022-03-11
Status
Completed
Treatment
Ceftazidime-avibactam
Non-Interventional Study
Arms:
Cohort 1
Size
204
Primary endpoint
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
Eligibility criteria
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
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'OTHER', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 204, 'type': 'ACTUAL'}}
Updated at
2023-01-23

1 organization

1 product

1 indication

Organization
Pfizer
Product
Ceftazidime-avibactam
Indication
Gram-negative Infections