Long-term evaluation of clinical success and safety of omadacycline in nontuberculous mycobacteria infections: a retrospective, multicenter cohort of real-world health outcomes

Antimicrob Agents Chemother. 2023 Oct 18;67(10):e0082423. doi: 10.1128/aac.00824-23. Epub 2023 Sep 28.

Abstract

Infections due to nontuberculous mycobacteria (NTM) continue to increase in prevalence, leading to problematic clinical outcomes. Omadacycline (OMC) is an aminomethylcycline antibiotic with FDA orphan drug and fast-track designations for pulmonary NTM infections, including Mycobacteroides abscessus (MAB). This multicenter retrospective study across 16 U.S. medical institutions from January 2020 to March 2023 examined the long-term clinical success, safety, and tolerability of OMC for NTM infections. The cohort included patients aged ≥18 yr, who were clinically evaluable, and` had been treated with OMC for ≥3 mo without a previous diagnosis of cystic fibrosis. The primary outcome was 3 mo clinical success, with secondary outcomes including clinical improvement and mortality at 6- and 12 mo, persistence or reemergence of infection, adverse effects, and reasons for OMC utilization. Seventy-five patients were included in this analysis. Most patients were female (48/75, 64.0%) or Caucasian (58/75, 77.3%), with a median (IQR) age of 59 yr (49-67). Most had NTM pulmonary disease (33/75, 44.0%), skin and soft tissue disease (19/75, 25.3%), or osteomyelitis (10/75, 13.3%), and Mycobacterium abscessus (60/75, 80%) was the most commonly isolated NTM pathogen. The median (IQR) treatment duration was 6 mo (4 - 14), and the most commonly co-administered antibiotic was azithromycin (33/70, 47.1%). Three-month clinical success was observed in 80.0% (60/75) of patients, and AEs attributable to OMC occurred in 32.0% (24/75) of patients, leading to drug discontinuation in 9.3% (7/75).

Keywords: Mycobacterium abscessus; culture conversion; nontuberculous mycobacteria; omadacycline.

Publication types

  • Multicenter Study

MeSH terms

  • Anti-Bacterial Agents / adverse effects
  • Cystic Fibrosis* / microbiology
  • Female
  • Humans
  • Male
  • Mycobacterium Infections, Nontuberculous* / microbiology
  • Mycobacterium abscessus*
  • Nontuberculous Mycobacteria
  • Outcome Assessment, Health Care
  • Retrospective Studies

Substances

  • omadacycline
  • Anti-Bacterial Agents