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

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.