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Browsing by Author "Simonyan, Anahit"
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Item Long-term evaluation of clinical success and safety of omadacycline in nontuberculous mycobacteria infections: a retrospective, multicenter cohort of real-world health outcomes(American Society for Microbiology, 2023) El Ghali, Amer; Morrisette, Taylor; Alosaimy, Sara; Lucas, Kristen; Tupayachi-Ortiz, Maria G.; Vemula, Raaga; Wadle, Carly; Philley, Julie V.; Mejia-Chew, Carlos; Hamad, Yasir; Stevens, Ryan W.; Zeuli, John D.; Webb, Andrew J.; Fiske, Christina T.; Simonyan, Anahit; Cimino, Christo L.; Mammadova, Mehriban; Umana, Virginia E.; Hasbun, Rodrigo; Butt, Saira; Molina, Kyle C.; Thomas, Michael; Kaip, Emily A.; Bouchard, Jeannette; Gore, Tristan W.; Howard, Catessa; Cabanilla, M. Gabriela; Holger, Dana J.; Frens, Jeremy J.; Barger, Melissa; Ong, Aaron; Cohen, Keira A.; Rybak, Michael J.; Medicine, School of MedicineInfections 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).