Document Type
Article
Publication Date
9-28-2023
Publication Title
Antimicrobial Agents and Chemotherapy
Keywords
Mycobacterium abscessus, culture conversion, nontuberculous mycobacteria, omadacycline.
ISSN
1098-6596
First Page
0082423
Last Page
0082423
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).
Creative Commons License
This work is licensed under a Creative Commons Attribution 4.0 International License.
NSUWorks Citation
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; and Rybak, Michael J, "Long-term evaluation of clinical success and safety of omadacycline in nontuberculous mycobacteria infections: a retrospective, multicenter cohort of real-world health outcomes." (2023). HPD Articles. 355.
https://nsuworks.nova.edu/hpd_facarticles/355
ORCID ID
0000-0003-1744-0048, 0000-0001-7700-151X, 0000-0003-3607-8849, 0000-0003-0528-4252, 0000-0001-6616-7127, 0000-0003-2165-7354, 0000-0002-6290-0026, 0000-0003-3273-8379, 0000-0003-0626-9695, 0000-0001-5402-0240, 0000-0001-7171-7015, 0009-0009-5360-707X, 0000-0002-4521-397X, 0000-0003-2220-0081.
DOI
10.1128/aac.00824-23
Copyright
Copyright © 2023 El Ghali et al.
Comments
This work was supported by an investigator-initiated grant from Paratek Pharmaceuticals. The funders had no role in the study design, data collection and interpretation, or decision to submit the work for publication. A.E., T.M., K.L., M.G.T-O., R.V., C.W., Y.H., R.W.S., J.D.Z, A.J.W., A.S., C.L.C, M.M., V.E.U, S.B., K.C.M., M.T., E.A.K., J.B., T.W.G., C.H., M.G.C., D.J.H., J.J.F., M.L.B., A.O., J.S. have no conflicts of interest to disclose. S.A. is currently an employee of Aimmune Therapeutics, a Nestle Company. J.V.P. has been on advisory boards for Insmed, A2N, Paratek Pharmaceuticals, and Cipla Technologies, and has spoken for Insmed. M.P.V. received research funding from Paratek Pharmaceuticals, Cumberland Pharmaceuticals, Insmed, AN2, Spero, Hillrom, and Electromed. C.M-C. has consulted for HIVE Medical Inc, and has received grant funding from the CDC (CDC# 1U54CK000617-01-00). C.T.F. has spoken for Insmed. R.H. has consulted for and received research funding from Biofire Diagnostics. K.A.C. is currently employed by Janssen pharmaceutical companies of Johnson & Johnson and has received consulting fees from Insmed, Hillrom, Merck, and Microbion, and AN2, unrelated to the current investigation, and was supported by National Heart, Lung, and Blood Institute K08 HL1139994 and the Burroughs Welcome Fund Career Award for Medical Scientists. M.J.R. has received funds for research and consulting or participated in speaking bureaus for Abbvie, Baselia, Ferring, Melinta, Merck, Paratek Pharmaceuticals, Shionogi, Tetraphase, and T2 Biosystems and is partially supported by National Institute of Allergy and Infectious Diseases R21 AI163726. Conflicts that the editors considered relevant to the content of the manuscript have been disclosed. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.