The efficacy and safety of omadacycline in treating acute bacterial infections: a meta-analysis of randomized controlled trials.

Introduction: This study aimed to reevaluate the clinical efficacy and safety of omadacycline in treating acute bacterial infections.

Methods: We searched PubMed, Embase, Cochrane Library, Web of Science, and Clinical Trials up to 1 January 2024, including only randomized controlled trials comparing OMC with other antibiotics in adults. Primary outcomes were clinical and microbiological responses; secondary outcomes included adverse events.

Results: Seven RCTs with 2957 patients met the inclusion criteria. OMC showed a slightly better clinical response at the post-therapy evaluation phase in the clinically evaluable population (RR = 1.03, 95% CI = 1.01-1.05, I² = 0%). Microbial eradication rates for Gram-positive and Gram-negative infections showed no significant differences between OMC and comparators. Safety analysis revealed no significant differences in overall AEs, treatment-related AEs, serious AEs, or drug discontinuation due to AEs. However, OMC had a lower risk of diarrhea (RR: 0.48, 95% CI = 0.23-1.00, I² = 65%). All-cause mortality did not differ significantly between OMC and comparators.

Conclusions: OMC is a safe and effective treatment for acute bacterial infections, comparable to other antibiotics.

Registration: This study has been registered in the online systematic review database (Prospective Register of Systematic Reviews [PROSPERO]), and the registration number is CRD42024575416.