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Published in: BMC Infectious Diseases 1/2023

Open Access 01-12-2023 | Linezolid | Research

Omadacycline for treatment of acute bacterial infections: a meta-analysis of phase II/III trials

Authors: Fei Lin, Rong He, Bin Yu, Bowen Deng, Baodong Ling, Mingyong Yuan

Published in: BMC Infectious Diseases | Issue 1/2023

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Abstract

Objective

This study aims to assess the clinical efficacy and safety of omadacycline for the treatment of acute bacterial infections.

Methods

A search of PubMed, Embase, Cochrane Library, and Clinical Trials was conducted up to July 1, 2022. We included only randomized controlled trials (RCTs), in which omadacycline and other antibiotics were evaluated for treating acute bacterial infections in adults. The primary outcomes were clinical response and microbiological response, whereas the secondary outcome was the risk of adverse events (AEs).

Results

A total of seven RCTs involving 2841 patients with acute bacterial infection were included. Overall, our study illustrated that the clinical cure ratio of omadacycline was similar to the comparators in the treatment of acute bacterial infections (OR = 1.18, 95%CI = 0.96, 1.46, I2 = 29%). Omadacycline had a microbiological eradication rate similar to comparators in the treatment of acute bacterial infections (OR = 1.02, 95%CI = 0.81, 1.29, I2 = 42%). No statistical differences were observed between omadacycline and the comparators in terms of infection caused by Staphylococcus aureus (OR = 1.14, 95%CI = 0.80, 1.63, I2 = 0%), methicillin-resistant S. aureus (MRSA, OR = 1.28, 95%CI = 0.73, 2.24, I2 = 0%), methicillin-susceptible S. aureus (MSSA, OR = 1.12, 95%CI = 0.69, 1.81, I2 = 0%), and Enterococcus faecalis (OR = 2.47, 95%CI = 0.36, 16.97, I2 = 7%). A significant difference was found between omadacycline and the comparators for the risk of any AEs and treatment related AEs. The risk of discontinuation of the study drug due to an AEs was lower for omadacycline than for the comparators.

Conclusion

Omadacycline is as good as comparators in terms of efficacy and tolerance in the treatment of acute bacterial infections in adult patients. Thus, omadacycline is an appropriate option for antibiotic therapy in adult patients with acute bacterial infections.
Literature
1.
go back to reference Paul M, et al. European Society of Clinical Microbiology and Infectious Diseases (ESCMID) guidelines for the treatment of infections caused by multidrug-resistant Gram-negative bacilli (endorsed by european society of intensive care medicine). Clin Microbiol Infect. 2022;28(4):521–47.CrossRefPubMed Paul M, et al. European Society of Clinical Microbiology and Infectious Diseases (ESCMID) guidelines for the treatment of infections caused by multidrug-resistant Gram-negative bacilli (endorsed by european society of intensive care medicine). Clin Microbiol Infect. 2022;28(4):521–47.CrossRefPubMed
2.
go back to reference Hasan CM, Dutta D, Nguyen ANT. Revisiting Antibiotic Resistance: Mechanistic Foundations to Evolutionary Outlook.Antibiotics (Basel), 2021. 11(1). Hasan CM, Dutta D, Nguyen ANT. Revisiting Antibiotic Resistance: Mechanistic Foundations to Evolutionary Outlook.Antibiotics (Basel), 2021. 11(1).
3.
4.
go back to reference Jean SS, et al. New drugs for Multidrug-Resistant Gram-Negative organisms: time for stewardship. Drugs. 2019;79(7):705–14.CrossRefPubMed Jean SS, et al. New drugs for Multidrug-Resistant Gram-Negative organisms: time for stewardship. Drugs. 2019;79(7):705–14.CrossRefPubMed
5.
go back to reference Koulenti D et al. Novel Antibiotics for Multidrug-Resistant Gram-Positive Microorganisms.Microorganisms, 2019. 7(8). Koulenti D et al. Novel Antibiotics for Multidrug-Resistant Gram-Positive Microorganisms.Microorganisms, 2019. 7(8).
6.
go back to reference Andrei S, Droc G, Stefan G. FDA approved antibacterial drugs: 2018–2019. Discoveries (Craiova), 2019. 7(4): e102. Andrei S, Droc G, Stefan G. FDA approved antibacterial drugs: 2018–2019. Discoveries (Craiova), 2019. 7(4): e102.
7.
go back to reference Markham A, Keam SJ. Omadacycline: First Global Approval. Drugs, 2018. 78(18): 1931–1937. Markham A, Keam SJ. Omadacycline: First Global Approval. Drugs, 2018. 78(18): 1931–1937.
8.
go back to reference Dougherty JA, et al. Omadacycline: a New Tetracycline Antibiotic. Ann Pharmacother. 2019;53(5):486–500.CrossRefPubMed Dougherty JA, et al. Omadacycline: a New Tetracycline Antibiotic. Ann Pharmacother. 2019;53(5):486–500.CrossRefPubMed
9.
go back to reference Gallagher JC. Omadacycline: a modernized tetracycline. Clin Infect Dis. 2019;69(Suppl 1):1–s5.CrossRef Gallagher JC. Omadacycline: a modernized tetracycline. Clin Infect Dis. 2019;69(Suppl 1):1–s5.CrossRef
10.
11.
go back to reference Dong D, et al. In vitro activity of omadacycline against pathogens isolated from Mainland China during 2017–2018. Eur J Clin Microbiol Infect Dis. 2020;39(8):1559–72.CrossRefPubMed Dong D, et al. In vitro activity of omadacycline against pathogens isolated from Mainland China during 2017–2018. Eur J Clin Microbiol Infect Dis. 2020;39(8):1559–72.CrossRefPubMed
12.
go back to reference Li H, et al. Efficacy and safety of optional parenteral antimicrobial therapy for complicated skin and soft tissue infections: a systematic review and bayesian network meta-analysis. Med (Baltim). 2022;101(34):e30120.CrossRef Li H, et al. Efficacy and safety of optional parenteral antimicrobial therapy for complicated skin and soft tissue infections: a systematic review and bayesian network meta-analysis. Med (Baltim). 2022;101(34):e30120.CrossRef
13.
go back to reference Moran GJ, Chitra S, McGovern PC. Efficacy and safety of Omadacycline Versus Linezolid in Acute bacterial skin and skin structure infections in persons who inject drugs. Infect Dis Ther. 2022;11(1):517–31.CrossRefPubMedPubMedCentral Moran GJ, Chitra S, McGovern PC. Efficacy and safety of Omadacycline Versus Linezolid in Acute bacterial skin and skin structure infections in persons who inject drugs. Infect Dis Ther. 2022;11(1):517–31.CrossRefPubMedPubMedCentral
14.
15.
go back to reference Puljak L, et al. Cochrane risk of bias tool was used inadequately in the majority of non-cochrane systematic reviews. J Clin Epidemiol. 2020;123:114–9.CrossRefPubMed Puljak L, et al. Cochrane risk of bias tool was used inadequately in the majority of non-cochrane systematic reviews. J Clin Epidemiol. 2020;123:114–9.CrossRefPubMed
16.
go back to reference Noel GJ, et al. A randomized, evaluator-blind, phase 2 study comparing the safety and efficacy of omadacycline to those of linezolid for treatment of complicated skin and skin structure infections. Antimicrob Agents Chemother. 2012;56(11):5650–4.CrossRefPubMedPubMedCentral Noel GJ, et al. A randomized, evaluator-blind, phase 2 study comparing the safety and efficacy of omadacycline to those of linezolid for treatment of complicated skin and skin structure infections. Antimicrob Agents Chemother. 2012;56(11):5650–4.CrossRefPubMedPubMedCentral
17.
go back to reference O’Riordan W, et al. Omadacycline for Acute bacterial skin and skin-structure infections. N Engl J Med. 2019;380(6):528–38.CrossRefPubMed O’Riordan W, et al. Omadacycline for Acute bacterial skin and skin-structure infections. N Engl J Med. 2019;380(6):528–38.CrossRefPubMed
18.
go back to reference Stets R, et al. Omadacycline for Community-Acquired Bacterial Pneumonia. N Engl J Med. 2019;380(6):517–27.CrossRefPubMed Stets R, et al. Omadacycline for Community-Acquired Bacterial Pneumonia. N Engl J Med. 2019;380(6):517–27.CrossRefPubMed
19.
go back to reference O’Riordan W, et al. Once-daily oral omadacycline versus twice-daily oral linezolid for acute bacterial skin and skin structure infections (OASIS-2): a phase 3, double-blind, multicentre, randomised, controlled, non-inferiority trial. Lancet Infect Dis. 2019;19(10):1080–90.CrossRefPubMed O’Riordan W, et al. Once-daily oral omadacycline versus twice-daily oral linezolid for acute bacterial skin and skin structure infections (OASIS-2): a phase 3, double-blind, multicentre, randomised, controlled, non-inferiority trial. Lancet Infect Dis. 2019;19(10):1080–90.CrossRefPubMed
20.
go back to reference Rusu A, Buta EL. The Development of Third-Generation Tetracycline Antibiotics and New Perspectives.Pharmaceutics, 2021. 13(12). Rusu A, Buta EL. The Development of Third-Generation Tetracycline Antibiotics and New Perspectives.Pharmaceutics, 2021. 13(12).
21.
go back to reference Pfaller MA et al. Surveillance of Omadacycline Activity Tested against Clinical Isolates from the United States and Europe: Report from the SENTRY Antimicrobial Surveillance Program, 2016 to 2018.Antimicrob Agents Chemother, 2020. 64(5). Pfaller MA et al. Surveillance of Omadacycline Activity Tested against Clinical Isolates from the United States and Europe: Report from the SENTRY Antimicrobial Surveillance Program, 2016 to 2018.Antimicrob Agents Chemother, 2020. 64(5).
22.
go back to reference Huband MD, et al. In Vitro Activity of Omadacycline against 7000 bacterial pathogens from the United States stratified by infection type (2019). Open Forum Infectious Diseases. 2020;7(SUPPL 1):644.CrossRef Huband MD, et al. In Vitro Activity of Omadacycline against 7000 bacterial pathogens from the United States stratified by infection type (2019). Open Forum Infectious Diseases. 2020;7(SUPPL 1):644.CrossRef
23.
go back to reference Pfaller MA et al. Surveillance of Omadacycline Activity against Clinical Isolates from a Global Collection (North America, Europe, Latin America, Asia-Western Pacific), 2010–2011.Antimicrob Agents Chemother, 2017. 61(5). Pfaller MA et al. Surveillance of Omadacycline Activity against Clinical Isolates from a Global Collection (North America, Europe, Latin America, Asia-Western Pacific), 2010–2011.Antimicrob Agents Chemother, 2017. 61(5).
24.
go back to reference Pfaller MA et al. Surveillance of Omadacycline Activity Tested against Clinical Isolates from the United States and Europe as Part of the 2016 SENTRY Antimicrobial Surveillance Program.Antimicrob Agents Chemother, 2018. 62(4). Pfaller MA et al. Surveillance of Omadacycline Activity Tested against Clinical Isolates from the United States and Europe as Part of the 2016 SENTRY Antimicrobial Surveillance Program.Antimicrob Agents Chemother, 2018. 62(4).
25.
go back to reference Huband MD, et al. Surveillance of omadacycline activity tested against clinical isolates from the United States and Europe: results from the SENTRY Antimicrobial Surveillance Programme, 2017. J Glob Antimicrob Resist. 2019;19:56–63.CrossRefPubMed Huband MD, et al. Surveillance of omadacycline activity tested against clinical isolates from the United States and Europe: results from the SENTRY Antimicrobial Surveillance Programme, 2017. J Glob Antimicrob Resist. 2019;19:56–63.CrossRefPubMed
26.
go back to reference Pfaller MA, et al. Surveillance of omadacycline activity tested against clinical isolates from the USA: report from the SENTRY Antimicrobial Surveillance Program, 2019. J Glob Antimicrob Resist. 2021;27:337–51.CrossRefPubMed Pfaller MA, et al. Surveillance of omadacycline activity tested against clinical isolates from the USA: report from the SENTRY Antimicrobial Surveillance Program, 2019. J Glob Antimicrob Resist. 2021;27:337–51.CrossRefPubMed
27.
go back to reference Xiao M, et al. Antimicrobial activity of omadacycline in vitro against bacteria isolated from 2014 to 2017 in China, a multi-center study. BMC Microbiol. 2020;20(1):350.CrossRefPubMedPubMedCentral Xiao M, et al. Antimicrobial activity of omadacycline in vitro against bacteria isolated from 2014 to 2017 in China, a multi-center study. BMC Microbiol. 2020;20(1):350.CrossRefPubMedPubMedCentral
28.
go back to reference Durães F, Sousa E. Omadacycline: A Newly Approved Antibacterial from the Class of Tetracyclines.Pharmaceuticals (Basel), 2019. 12(2). Durães F, Sousa E. Omadacycline: A Newly Approved Antibacterial from the Class of Tetracyclines.Pharmaceuticals (Basel), 2019. 12(2).
29.
go back to reference Lan SH, et al. The efficacy and safety of omadacycline in treatment of acute bacterial infection: a systemic review and meta-analysis of randomized controlled trials. Med (Baltim). 2019;98(51):e18426.CrossRef Lan SH, et al. The efficacy and safety of omadacycline in treatment of acute bacterial infection: a systemic review and meta-analysis of randomized controlled trials. Med (Baltim). 2019;98(51):e18426.CrossRef
30.
go back to reference Lan SH et al. The Efficacy and Safety of Eravacycline in the Treatment of Complicated Intra-Abdominal Infections: A Systemic Review and Meta-Analysis of Randomized Controlled Trials.J Clin Med, 2019. 8(6). Lan SH et al. The Efficacy and Safety of Eravacycline in the Treatment of Complicated Intra-Abdominal Infections: A Systemic Review and Meta-Analysis of Randomized Controlled Trials.J Clin Med, 2019. 8(6).
Metadata
Title
Omadacycline for treatment of acute bacterial infections: a meta-analysis of phase II/III trials
Authors
Fei Lin
Rong He
Bin Yu
Bowen Deng
Baodong Ling
Mingyong Yuan
Publication date
01-12-2023
Publisher
BioMed Central
Published in
BMC Infectious Diseases / Issue 1/2023
Electronic ISSN: 1471-2334
DOI
https://doi.org/10.1186/s12879-023-08212-0

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