The efficacy and safety of omadacycline in treatment of acute bacterial infection

Abstract Background: This study aims to assess the clinical efficacy and safety of omadacycline for the treatment of acute bacterial infections in adult patients through meta-analysis. Methods: PubMed, Embase, ClinicalTrials.gov, and Cochrane databases were searched up to May 2019. Only randomized controlled trials (RCTs) that evaluated omadacycline and other comparators for treating acute bacterial infections in adult patients were included. The primary outcome was the clinical response rate at the posttreatment evaluation, whereas the secondary outcomes were risk of an adverse event (AE) and mortality. Results: Four RCTs were included. Overall, omadacycline had a clinical response rate noninferior to comparators in the treatment of acute bacterial infection in the modified intent-to-treat population (odds ratio [OR], 1.31; 95% confidence interval [CI], 1.04–1.65; I 2 = 0%) and in the clinically evaluable population (OR, 1.53; 95% CI, 1.11–2.11; I 2 = 0%). Furthermore, no significant differences were found between omadacycline and comparators for the risk of treatment-emergent AEs (OR, 1.13; 95% CI, 0.60–2.14; I 2 = 93%), treatment-related AEs (OR, 0.70; 95% CI, 0.46–1.04; I 2 = 56%), serious AEs (OR, 1.01; 95% CI, 0.64–1.58; I 2 = 0%), and discontinuation of study drug due to an AE (OR, 0.78; 95% CI, 0.47–1.29; I 2 = 0%). However, in the clinical trial, NCT02877927, in which omadacycline was used in only oral form, the reported incidence of nausea and vomiting were 30.2% (111/368) and 16.9% (62/368), respectively. Finally, the mortality rate was similar between omadacycline and comparator in the treatment of acute bacterial infection (OR, 1.32; 95% CI, 0.47–3.67; I 2 = 0%). Conclusion: The clinical efficacy of omadacycline is not inferior to that of comparators in the treatment of acute bacterial infections in adult patients, and this antibiotic is also well tolerated.