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Background <p>Omadacycline (OMC) is an aminomethylcycline antibiotic approved in 2018 for the treatment of acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia in adults. This study assessed the effectiveness and safety of OMC in real-world clinical settings across the United States.</p> Methods <p>We conducted a multicenter, retrospective cohort study at 12 U.S. medical centers including adults who received OMC between October 2018 and October 2023. The primary outcome for definitive therapy was clinical cure, defined as resolution of infectious signs and symptoms without the need for alternative therapy due to concern for failure. For suppressive therapy, the primary outcome was breakthrough infection within 90 days, defined as recurrence with the same pathogen at the same site. Secondary outcomes included 30-day survival, recurrence, readmission, and adverse effects (AEs).</p> Results <p>Eighty-six patients were included; median (interquartile range [IQR]) age was 63 years (46.0–66.0), 52.3% were male, and 67.4% were white. Most received outpatient therapy (84.9%). The median Charlson Comorbidity Index was 8.5. Common infections included osteomyelitis (30.2%) and skin/soft tissue infections (27.9%). OMC was used as targeted therapy in 69.8% and as suppressive therapy in 30.2%. Clinical cure was achieved in 81.7%, and 30-day survival was 95.3%. Microbiologic recurrence occurred in 10.3% and breakthrough infection in 15.4%. AEs were reported in 19.8%, predominantly gastrointestinal (88.2%).</p> Conclusion <p>OMC demonstrated high clinical effectiveness and tolerability across a range of infections, supporting its role in patients with resistant pathogens or limited treatment options. Further prospective studies are warranted.</p> Clinical trial registration <p>Not applicable.</p>

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Beyond traditional tetracyclines: a real-world evaluation of effectiveness and safety of omadacycline therapy for complex bacterial infections

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年5月25日

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  • Mohammed Al Musawa,
  • Amer El Ghali,
  • Taylor Morrisette,
  • Andrea L. Banks,
  • Mohammed Saeedi,
  • Monica Mahoney,
  • Madison Salam,
  • Emily Sinclair,
  • Brandon Chen,
  • Kyle C. Molina,
  • Michael Thomas,
  • John Zeuli,
  • Andrew J. Webb,
  • Dana J. Holger,
  • Maria G. Tupayachi-Ortiz,
  • Jeannette Bouchard,
  • Michael P. Veve,
  • Taryn A. Eubank,
  • Karan Raja,
  • Maureen Campion,
  • Ryan W. Stevens,
  • Michael J. Rybak

摘要

Background

Omadacycline (OMC) is an aminomethylcycline antibiotic approved in 2018 for the treatment of acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia in adults. This study assessed the effectiveness and safety of OMC in real-world clinical settings across the United States.

Methods

We conducted a multicenter, retrospective cohort study at 12 U.S. medical centers including adults who received OMC between October 2018 and October 2023. The primary outcome for definitive therapy was clinical cure, defined as resolution of infectious signs and symptoms without the need for alternative therapy due to concern for failure. For suppressive therapy, the primary outcome was breakthrough infection within 90 days, defined as recurrence with the same pathogen at the same site. Secondary outcomes included 30-day survival, recurrence, readmission, and adverse effects (AEs).

Results

Eighty-six patients were included; median (interquartile range [IQR]) age was 63 years (46.0–66.0), 52.3% were male, and 67.4% were white. Most received outpatient therapy (84.9%). The median Charlson Comorbidity Index was 8.5. Common infections included osteomyelitis (30.2%) and skin/soft tissue infections (27.9%). OMC was used as targeted therapy in 69.8% and as suppressive therapy in 30.2%. Clinical cure was achieved in 81.7%, and 30-day survival was 95.3%. Microbiologic recurrence occurred in 10.3% and breakthrough infection in 15.4%. AEs were reported in 19.8%, predominantly gastrointestinal (88.2%).

Conclusion

OMC demonstrated high clinical effectiveness and tolerability across a range of infections, supporting its role in patients with resistant pathogens or limited treatment options. Further prospective studies are warranted.

Clinical trial registration

Not applicable.