N/A
N=189
Retrospective Analysis of Real World Use of Ceftazidime-avibactam in the Management of Gram Negative Infections
Gram Negative Infections
Bottom Line
View on ClinicalTrials.gov: NCT04628572 ↗Enrolled (actual)
189
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Number of Participants With Clinical Symptom Improvement at Day 3 — 82; 21 Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Ceftazidime-avibactam (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Clinical Symptom Improvement at Day 3 |
82; 21 | — |
| PRIMARY Number of Participants With Treatment Success at Day 7 |
66; 12; 5 | — |
| PRIMARY Number of Participants With Treatment Success at Day 14 or End of Treatment |
45; 13; 1 | — |
| PRIMARY Number of Participants With Microbiological Success at Day 7 |
31; 7 | — |
| PRIMARY Number of Participants With Microbiological Success at Day 14 or End of Treatment |
24; 17 | — |
| PRIMARY Number of Participants With Serious Adverse Events and Non-Serious Adverse Events With Explicit Attribution to Ceftazidime-Avibactam |
0; 0 | — |
| SECONDARY Number of Participants Classified According to Source of Infection at Baseline for Which Ceftazidime-Avibactam Was Used |
72; 65; 52 | — |
| SECONDARY Number of Participants According to Indication at Baseline for Which Ceftazidime-Avibactam Was Used |
55; 30; 55; 49 | — |
| SECONDARY Dose of Ceftazidime - Avibactam |
2500 | — |
| SECONDARY Number of Participants According to Frequency of Administration |
71; 22; 96 | — |
| SECONDARY Duration of Administration of Ceftazidime - Avibactam |
2.1 | — |
| SECONDARY Total Duration of Therapy of Ceftazidime-Avibactam |
6.92 | — |
| SECONDARY Number of Participants Who Received Concomitant Antibiotics With Ceftazidime-Avibactam |
156 | — |
| SECONDARY Number of Participants With History of Antibiotic Exposure |
126 | — |
| SECONDARY Number of Participants According to Identified Gram Negative Organisms |
57; 15; 11; 4; 1; 1 | — |
| SECONDARY Number of Participants With Identified Pathogens Susceptible to Ceftazidime-Avibactam |
34 | — |
| SECONDARY Duration of Hospital Stay |
23.1 | — |
| SECONDARY Duration of Stay in Intensive Care Unit (ICU) |
15.7 | — |
| SECONDARY Number of Participants According to Healthcare Resource Utilization |
82; 59; 36; 25; 16; 5 | — |
| SECONDARY Number of Participants With Recurrence of Infection |
8 | — |
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.
Eligibility Criteria
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.
- Patient with documented Acinetobacter infection.
- Patient was a part of named access program or any other interventional study
Data sourced from ClinicalTrials.gov (NCT04628572). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.