Open AccessCeftazidime-avibactam plus metronidazole vs. meropenem in complicated intra-abdominal infections: Indian subset from RECLAIM
Author(s) -
Prithi Rodgers,
Shweta Kamat,
Charles Adhav
Publication year - 2022
Publication title -
journal of infection in developing countries
Language(s) - English
Resource type - Journals
eISSN - 2036-6590
pISSN - 1972-2680
DOI - 10.3855/jidc.14912
Subject(s) - metronidazole , meropenem , ceftazidime/avibactam , medicine , population , ceftazidime , randomized controlled trial , surgery , antibiotics , gastroenterology , microbiology and biotechnology , antibiotic resistance , biology , genetics , environmental health , bacteria , pseudomonas aeruginosa
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.