ORIGINAL RESEARCH article
Front. Pharmacol.
Sec. Pharmacology of Infectious Diseases
Efficacy and safety of omadacycline for the treatment of infectious diseases: a real-world, retrospective study of 2587 patients
Provisionally accepted
- 1Department of Pharmacy, the First Affiliated Hospital, Jiangxi Medical College, Nanchang University, Nanchang, China
- 2College of Pharmacy, Yichun University, Yichun, China
- 3Department of Pharmacy, Affiliated Tumor Hospital of Guangxi Medical University, Nanning, China
- 4Department of Pharmacy, YongFeng County Medicine Hospital, Ji’an, China
- 5Department of Pharmacy, The People's Hospital of Hezhou, Hezhou, China
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Objective: Previous randomized controlled trials have shown good efficacy and safety of omadacycline in patients with infectious diseases, but relevant real-world evidence is still insufficient. This large-scale study aimed to explore the efficacy and safety of omadacycline for the treatment of infectious diseases in real-world conditions. Methods: This was a retrospective, real-world study. A total of 2587 patients with infectious diseases who received omadacycline treatment were enrolled. Clinical success was defined as resolution or significant improvement of infection-related signs and symptoms without the need for salvage antimicrobial therapy. Results: After omadacycline treatment, 81.6% of patients achieved clinical success. Multivariate logistic regression analysis suggested that older age [odds ratio (OR): 0.991, P=0.025], history of any malignancy (OR: 0.630, P=0.016), abnormal renal function (OR: 0.432, P=0.003), mechanical ventilation (OR: 0.559, P=0.013), intensive care unit (ICU) (OR: 0.328, P<0.001), and longer length of stay (LOS) (OR: 0.941, P<0.001) were independently related to a lower probability of achieving clinical success. However, longer days of omadacycline use were independently associated with a higher probability of achieving clinical success (OR: 1.121, P<0.001). Regarding adverse events, the incidence of coagulation disorders, acute kidney injury, liver injury, and gastrointestinal reaction was 10.5%, 9.9%, 6.2%, and 5.3%, respectively. Conclusion: Omadacycline possesses favorable efficacy and safety for the treatment of infectious diseases. Baseline age, malignancy history, renal function, mechanical ventilation, ICU, LOS, and omadacycline use duration are strong predictors of clinical success.
Keywords: infectious diseases, omadacycline, efficacy, Safety, predictors
Received: 16 Sep 2025; Accepted: 31 Oct 2025.
Copyright: © 2025 Liu, Liu, Li, Pang, Chen, Liu and Ouyang. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Aijun Ouyang, aijun_ouyang@163.com
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