Retrospective Analysis of Real World Use of Ceftazidime-avibactam in the Management of Gram Negat… (NCT04628572) | Clinical Trial Compass
CompletedNot Applicable
Retrospective Analysis of Real World Use of Ceftazidime-avibactam in the Management of Gram Negative Infections
India189 participantsStarted 2021-01-29
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. more than or equal to 18 years of age
. Admitted to hospital with documented gram negative infection
. Has received treatment for atleast 48 hours (complete) with Ceftazidime-Avibactam as a part of his routine clinical management
Exclusion criteria
. The patient is enrolled in any clinical trial of an investigational product
. Age \<18 years
. Received Ceftazidime avibactam for less than 48 hours.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants With Clinical Symptom Improvement at Day 3
Timeframe: Day 3 after ceftazidime-avibactam initiation
2
Number of Participants With Treatment Success at Day 7
Timeframe: Day 7 after ceftazidime-avibactam initiation
3
Number of Participants With Treatment Success at Day 14 or End of Treatment
Timeframe: Day 14 or End of Treatment after ceftazidime-avibactam initiation, whichever was earlier
4
Number of Participants With Microbiological Success at Day 7
Timeframe: Day 7 after ceftazidime-avibactam initiation
5
Number of Participants With Microbiological Success at Day 14 or End of Treatment
Timeframe: Day 14 or End of Treatment after ceftazidime-avibactam initiation, whichever was earlier
6
Number of Participants With Serious Adverse Events and Non-Serious Adverse Events With Explicit Attribution to Ceftazidime-Avibactam
Timeframe: Up to 30 days post treatment completion with ceftazidime-avibactam, death or discharge; whichever was first (Up to maximum of 49 days)