Ceftazidime-avibactam plus metronidazole vs. meropenem in complicated intra-abdominal infections: Indian subset from
Prithi Rodgers1, Shweta Kamat2, Charles Adhav3
1Sahyadri Hospitals, Pune, India.
Introduction:
This study analyzes the safety and efficacy results of the Indian population subset from the RECLAIM trial investigating the non-inferiority of Ceftazidime-Avibactam (CAZ-AVI) plus metronidazole to meropenem and interprets its relevance.
Methodology:
The study design, subjects inclusion criteria, dosage, safety and efficacy evaluations in Indian patients have been followed as per the RECLAIM trial protocol.
Results:
A total of 142 Indian patients with complicated intra-abdominal infection were enrolled across eight centers in India, 125 of them were randomized to either CAZ-AVI + metronidazole (n = 62) or meropenem (n = 63) group. the clinical cure rates in modified intention-to-treat (MITT; all randomized patients who met minimum disease requirements and received any amount of study drug) and clinically evaluable (CE , patients who had an evaluable assessment and no protocol deviations) analysis sets, was numerically comparable to the results of overall population for CAZ-AVI + metronidazole [MITT: 82.5% (Overall, n = 429/520) versus 89.3% (Indian, n = 50/56); CE: 91.7% (Overall, n = 376/410) versus 97.8% (Indian, n = 45/46)] and meropenem [MITT: 84.9% (Overall, n = 444/523) versus 84.7% (Indian, n = 50/59); CE: 92.5% (Overall, n = 385/416) versus 95.5% (Indian, n = 42/44)]. No new safety findings were reported in the Indian population.
Conclusions:
CAZ-AVI + metronidazole proved to be an effective option for critical patients with complicated intra-abdominal infection and can be considered as an alternative to carbapenems in the ICU setting for the treatment of resistant pathogens.
Insights
Ceftazidime-avibactam plus metronidazole demonstrated comparable efficacy and safety to meropenem in Indian patients with complicated intra-abdominal infections. This combination offers a viable alternative treatment option for critical infections in intensive care units.
Area of Science:
- Infectious Diseases
- Clinical Pharmacology
- Critical Care Medicine
Background:
- Complicated intra-abdominal infections (cIAI) pose significant treatment challenges, particularly with the rise of antimicrobial resistance.
- Carbapenems are standard therapy, but alternatives are needed for resistant pathogens and specific patient populations.
- The RECLAIM trial evaluated Ceftazidime-avibactam (CAZ-AVI) plus metronidazole against meropenem for cIAI.
Purpose of the Study:
- To analyze the safety and efficacy of CAZ-AVI plus metronidazole in the Indian subset of patients from the RECLAIM trial.
- To assess the non-inferiority of CAZ-AVI plus metronidazole compared to meropenem in this specific population.
- To interpret the relevance of these findings for treating cIAI in India.
Main Methods:
- Retrospective analysis of Indian patients enrolled in the RECLAIM trial.
- Inclusion criteria, dosage, and safety/efficacy evaluations followed the RECLAIM protocol.
- Comparison of clinical cure rates between CAZ-AVI plus metronidazole and meropenem groups in modified intention-to-treat (MITT) and clinically evaluable (CE) sets.
Main Results:
- 142 Indian patients with cIAI were enrolled; 125 were randomized (62 to CAZ-AVI + metronidazole, 63 to meropenem).
- Clinical cure rates were numerically comparable between the treatment arms in both MITT and CE populations, mirroring overall trial results.
- No new safety concerns were identified in the Indian patient cohort.
Conclusions:
- CAZ-AVI plus metronidazole is an effective treatment for patients with cIAI, including those in intensive care settings.
- This combination can be considered a valuable alternative to carbapenems for treating infections caused by resistant bacteria.
- Findings support the use of CAZ-AVI plus metronidazole in the Indian context for managing complicated intra-abdominal infections.
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