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

Autor:	El Ghali A; Anti-Infective Research Laboratory, Department of Pharmacy Practice, Eugene Applebaum College of Pharmacy and Health Sciences, Wayne State University , Detroit, Michigan, USA., Morrisette T; Department of Clinical Pharmacy & Outcomes Sciences, Medical University of South Carolina College of Pharmacy , Charleston, South Carolina, USA.; Department of Pharmacy Services, Medical University of South Carolina (MUSC) Health , Charleston, South Carolina, USA., Alosaimy S; Anti-Infective Research Laboratory, Department of Pharmacy Practice, Eugene Applebaum College of Pharmacy and Health Sciences, Wayne State University , Detroit, Michigan, USA., Lucas K; Anti-Infective Research Laboratory, Department of Pharmacy Practice, Eugene Applebaum College of Pharmacy and Health Sciences, Wayne State University , Detroit, Michigan, USA., Tupayachi-Ortiz MG; Department of Medicine, Division of Pulmonary and Critical Care Medicine, Miller School of Medicine, University of Miami , Miami, Florida, USA., Vemula R; University of Texas Health Science Center, University of Texas , Tyler, Texas, USA., Wadle C; University of Texas Health Science Center, University of Texas , Tyler, Texas, USA., Philley JV; University of Texas Health Science Center, University of Texas , Tyler, Texas, USA., Mejia-Chew C; Division of Infectious Diseases, Department of Medicine, Washington University School of Medicine , St. Louis, Missouri, USA., Hamad Y; Division of Infectious Diseases, Department of Medicine, Washington University School of Medicine , St. Louis, Missouri, USA., Stevens RW; Department of Pharmacy, Mayo Clinic , Rochester, Minnesota, USA., Zeuli JD; Department of Pharmacy, Mayo Clinic , Rochester, Minnesota, USA., Webb AJ; Department of Pharmacy, Mayo Clinic , Rochester, Minnesota, USA., Fiske CT; Division of Infectious Diseases, Department of Medicine, Vanderbilt University Medical Center , Nashville, Tennessee, USA., Simonyan A; Department of Pharmaceutical Services, Vanderbilt University Medical Center , Nashville, Tennessee, USA., Cimino CL; Department of Pharmaceutical Services, Vanderbilt University Medical Center , Nashville, Tennessee, USA., Mammadova M; Division of Infectious Diseases, Department of Medicine, University of Texas Health Science Center at Houston , Houston, Texas, USA., Umana VE; Division of Infectious Diseases, Department of Medicine, University of Texas Health Science Center at Houston , Houston, Texas, USA., Hasbun R; Division of Infectious Diseases, Department of Medicine, University of Texas Health Science Center at Houston , Houston, Texas, USA., Butt S; Division of Infectious Diseases, Indiana University School of Medicine , Indianapolis, Indiana, USA., Molina KC; Department of Emergency Medicine, University of Colorado School of Medicine , Aurora, Colorado, USA., Thomas M; Department of Emergency Medicine, University of Colorado School of Medicine , Aurora, Colorado, USA., Kaip EA; Department of Pharmaceutical Services, University of California, San Francisco Medical Center , San Francisco, North Carolina, USA., Bouchard J; College of Pharmacy, University of South Carolina , Columbia, South Carolina, USA., Gore TW; College of Pharmacy, University of South Carolina , Columbia, South Carolina, USA., Howard C; Department of Pharmacy, West Virginia University Medicine , Morgantown, West Virginia, USA., Cabanilla MG; Division of Infectious Diseases, University of New Mexico Health Sciences Center , Albuquerque, New Mexico, USA., Holger DJ; Department of Pharmacy Practice, Barry and Judy Silverman College of Pharmacy, Nova Southeastern University , Fort Lauderdale, Florida, USA., Frens JJ; Department of Pharmacy Services, Cone Health , Greensboro, North Carolina, USA., Barger M; Department of Medicine, Ventura County Medical Center , Ventura, California, USA., Ong A; Division of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine , Baltimore, Marlyand, USA., Cohen KA; Division of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine , Baltimore, Marlyand, USA., Rybak MJ; Anti-Infective Research Laboratory, Department of Pharmacy Practice, Eugene Applebaum College of Pharmacy and Health Sciences, Wayne State University , Detroit, Michigan, USA.; Department of Medicine, Division of Infectious Diseases, School of Medicine, Wayne State University , Detroit, Michigan, USA.; Department of Pharmacy Services, Detroit Receiving Hospital, Detroit Medical Center , Detroit, Michigan, USA.
Jazyk:	angličtina
Zdroj:	Antimicrobial agents and chemotherapy [Antimicrob Agents Chemother] 2023 Oct 18; Vol. 67 (10), pp. e0082423. Date of Electronic Publication: 2023 Sep 28.
DOI:	10.1128/aac.00824-23
Abstrakt:	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). Competing Interests: 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.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.
Databáze:	MEDLINE
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