{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,23]],"date-time":"2026-10-23T23:38:42Z","timestamp":1792798722163,"version":"4.5.0"},"reference-count":34,"publisher":"American Society for Microbiology","issue":"10","license":[{"start":{"date-parts":[[2023,10,18]],"date-time":"2023-10-18T00:00:00Z","timestamp":1697587200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2023,10,18]],"date-time":"2023-10-18T00:00:00Z","timestamp":1697587200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.asm.org\/non-commercial-tdm-license"}],"funder":[{"name":"Paratek Pharmaceuticals","id":[{"id":"https:\/\/ror.org\/019g7bh20","id-type":"ROR","asserted-by":"crossref"}]}],"content-domain":{"domain":["journals.asm.org"],"crossmark-restriction":true},"short-container-title":["Antimicrob Agents Chemother"],"published-print":{"date-parts":[[2023,10,18]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n                  <jats:p>\n                    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\n                    <jats:italic>Mycobacteroides abscessus<\/jats:italic>\n                    (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 \u226518 yr, who were clinically evaluable, and` had been treated with OMC for \u22653 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\u201367). 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\n                    <jats:italic>Mycobacterium abscessus<\/jats:italic>\n                    (60\/75, 80%) was the most commonly isolated NTM pathogen. The median (IQR) treatment duration was 6 mo (\n                    <jats:xref ref-type=\"bibr\">4<\/jats:xref>\n                    <jats:xref ref-type=\"bibr\">\u2013<\/jats:xref>\n                    <jats:xref ref-type=\"bibr\">14<\/jats:xref>\n                    ), 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).\n                  <\/jats:p>","DOI":"10.1128\/aac.00824-23","type":"journal-article","created":{"date-parts":[[2023,9,28]],"date-time":"2023-09-28T10:37:25Z","timestamp":1695897445000},"update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":39,"title":["Long-term evaluation of clinical success and safety of omadacycline in nontuberculous mycobacteria infections: a retrospective, multicenter cohort of real-world health outcomes"],"prefix":"10.1128","volume":"67","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-1744-0048","authenticated-orcid":false,"given":"Amer","family":"El Ghali","sequence":"first","affiliation":[{"name":"Anti-Infective Research Laboratory, Department of Pharmacy Practice, Eugene Applebaum College of Pharmacy and Health Sciences, Wayne State University , Detroit, Michigan, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Taylor","family":"Morrisette","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacy &amp; Outcomes Sciences, Medical University of South Carolina College of Pharmacy , Charleston, South Carolina, USA"},{"name":"Department of Pharmacy Services, Medical University of South Carolina (MUSC) Health , Charleston, South Carolina, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sara","family":"Alosaimy","sequence":"additional","affiliation":[{"name":"Anti-Infective Research Laboratory, Department of Pharmacy Practice, Eugene Applebaum College of Pharmacy and Health Sciences, Wayne State University , Detroit, Michigan, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kristen","family":"Lucas","sequence":"additional","affiliation":[{"name":"Anti-Infective Research Laboratory, Department of Pharmacy Practice, Eugene Applebaum College of Pharmacy and Health Sciences, Wayne State University , Detroit, Michigan, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Maria G.","family":"Tupayachi-Ortiz","sequence":"additional","affiliation":[{"name":"Department of Medicine, Division of Pulmonary and Critical Care Medicine, Miller School of Medicine, University of Miami , Miami, Florida, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Raaga","family":"Vemula","sequence":"additional","affiliation":[{"name":"University of Texas Health Science Center, University of Texas , Tyler, Texas, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carly","family":"Wadle","sequence":"additional","affiliation":[{"name":"University of Texas Health Science Center, University of Texas , Tyler, Texas, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julie V.","family":"Philley","sequence":"additional","affiliation":[{"name":"University of Texas Health Science Center, University of Texas , Tyler, Texas, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Carlos","family":"Mejia-Chew","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases, Department of Medicine, Washington University School of Medicine , St. Louis, Missouri, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yasir","family":"Hamad","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases, Department of Medicine, Washington University School of Medicine , St. Louis, Missouri, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ryan W.","family":"Stevens","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Mayo Clinic , Rochester, Minnesota, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"John D.","family":"Zeuli","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Mayo Clinic , Rochester, Minnesota, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew J.","family":"Webb","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, Mayo Clinic , Rochester, Minnesota, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christina T.","family":"Fiske","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases, Department of Medicine, Vanderbilt University Medical Center , Nashville, Tennessee, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anahit","family":"Simonyan","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Services, Vanderbilt University Medical Center , Nashville, Tennessee, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christo L.","family":"Cimino","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Services, Vanderbilt University Medical Center , Nashville, Tennessee, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mehriban","family":"Mammadova","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases, Department of Medicine, University of Texas Health Science Center at Houston , Houston, Texas, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Virginia E.","family":"Umana","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases, Department of Medicine, University of Texas Health Science Center at Houston , Houston, Texas, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rodrigo","family":"Hasbun","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases, Department of Medicine, University of Texas Health Science Center at Houston , Houston, Texas, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Saira","family":"Butt","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases, Indiana University School of Medicine , Indianapolis, Indiana, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kyle C.","family":"Molina","sequence":"additional","affiliation":[{"name":"Department of Emergency Medicine, University of Colorado School of Medicine , Aurora, Colorado, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Thomas","sequence":"additional","affiliation":[{"name":"Department of Emergency Medicine, University of Colorado School of Medicine , Aurora, Colorado, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Emily A.","family":"Kaip","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutical Services, University of California, San Francisco Medical Center , San Francisco, North Carolina, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeannette","family":"Bouchard","sequence":"additional","affiliation":[{"name":"College of Pharmacy, University of South Carolina , Columbia, South Carolina, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tristan W.","family":"Gore","sequence":"additional","affiliation":[{"name":"College of Pharmacy, University of South Carolina , Columbia, South Carolina, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Catessa","family":"Howard","sequence":"additional","affiliation":[{"name":"Department of Pharmacy, West Virginia University Medicine , Morgantown, West Virginia, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M. Gabriela","family":"Cabanilla","sequence":"additional","affiliation":[{"name":"Division of Infectious Diseases, University of New Mexico Health Sciences Center , Albuquerque, New Mexico, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dana J.","family":"Holger","sequence":"additional","affiliation":[{"name":"Department of Pharmacy Practice, Barry and Judy Silverman College of Pharmacy, Nova Southeastern University , Fort Lauderdale, Florida, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jeremy J.","family":"Frens","sequence":"additional","affiliation":[{"name":"Department of Pharmacy Services, Cone Health , Greensboro, North Carolina, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Melissa","family":"Barger","sequence":"additional","affiliation":[{"name":"Department of Medicine, Ventura County Medical Center , Ventura, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aaron","family":"Ong","sequence":"additional","affiliation":[{"name":"Division of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine , Baltimore, Marlyand, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Keira A.","family":"Cohen","sequence":"additional","affiliation":[{"name":"Division of Pulmonary and Critical Care Medicine, Johns Hopkins University School of Medicine , Baltimore, Marlyand, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2220-0081","authenticated-orcid":false,"given":"Michael J.","family":"Rybak","sequence":"additional","affiliation":[{"name":"Anti-Infective Research Laboratory, Department of Pharmacy Practice, Eugene Applebaum College of Pharmacy and Health Sciences, Wayne State University , Detroit, Michigan, USA"},{"name":"Department of Medicine, Division of Infectious Diseases, School of Medicine, Wayne State University , Detroit, Michigan, USA"},{"name":"Department of Pharmacy Services, Detroit Receiving Hospital, Detroit Medical Center , Detroit, Michigan, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"235","reference":[{"key":"e_1_3_2_2_2","doi-asserted-by":"publisher","DOI":"10.3389\/fmicb.2018.00067"},{"key":"e_1_3_2_3_2","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciaa241"},{"key":"e_1_3_2_4_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.chest.2016.10.055"},{"key":"e_1_3_2_5_2","doi-asserted-by":"publisher","DOI":"10.1513\/AnnalsATS.201804-236OC"},{"key":"e_1_3_2_6_2","doi-asserted-by":"publisher","DOI":"10.1164\/rccm.201111-2016OC"},{"key":"e_1_3_2_7_2","doi-asserted-by":"publisher","DOI":"10.1513\/AnnalsATS.201709-727OC"},{"key":"e_1_3_2_8_2","doi-asserted-by":"publisher","DOI":"10.1055\/s-0038-1651494"},{"key":"e_1_3_2_9_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.diagmicrobio.2022.115882"},{"key":"e_1_3_2_10_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.chest.2021.07.035"},{"key":"e_1_3_2_11_2","unstructured":"Omadacycline [package insert]. Boston MA: Paratek Pharmaceuticals Inc.; 2018. www.accessdata.fda.gov\/drugsatfda_docs\/label\/2018\/209816_209817lbl.pdf."},{"key":"e_1_3_2_12_2","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciz242"},{"key":"e_1_3_2_13_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.02522-18"},{"key":"e_1_3_2_14_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.00470-19"},{"key":"e_1_3_2_15_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.01704-21"},{"key":"e_1_3_2_16_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.01947-20"},{"key":"e_1_3_2_17_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.01066-13"},{"key":"e_1_3_2_18_2","doi-asserted-by":"publisher","DOI":"10.3389\/fmicb.2018.02179"},{"key":"e_1_3_2_19_2","doi-asserted-by":"publisher","DOI":"10.3389\/fphar.2021.761167"},{"key":"e_1_3_2_20_2","doi-asserted-by":"publisher","DOI":"10.1007\/s11096-022-01397-5"},{"key":"e_1_3_2_21_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.01135-17"},{"key":"e_1_3_2_22_2","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciz398"},{"key":"e_1_3_2_23_2","unstructured":"Pharmaceuticals P. 2021. Paratek pharmaceuticals announces FDA orphan drug designation for NUZYRA\u00ae (omadacycline) for the treatment of infections caused by nontuberculous mycobacteria. GlobeNewswire News Room. https:\/\/www.globenewswire.com\/news-release\/2021\/08\/18\/2283087\/33636\/en\/Paratek-Pharmaceuticals-Announces-FDA-Orphan-Drug-Designation-for-NUZYRA-omadacycline-for-the-Treatment-of-Infections-Caused-by-Nontuberculous-Mycobacteria.html"},{"key":"e_1_3_2_24_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.00834-19"},{"key":"e_1_3_2_25_2","volume-title":"Antibacterial susceptibility test interpretive criteria","author":"Research C for DE and.","year":"2023","unstructured":"Research C for DE and. 2023. Antibacterial susceptibility test interpretive criteria. FDA."},{"key":"e_1_3_2_26_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.01275-08"},{"key":"e_1_3_2_27_2","doi-asserted-by":"publisher","DOI":"10.1093\/ofid\/ofab002"},{"key":"e_1_3_2_28_2","doi-asserted-by":"publisher","DOI":"10.1093\/ofid\/ofaa415"},{"key":"e_1_3_2_29_2","doi-asserted-by":"publisher","DOI":"10.7759\/cureus.5112"},{"key":"e_1_3_2_30_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1800201"},{"key":"e_1_3_2_31_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1800170"},{"key":"e_1_3_2_32_2","doi-asserted-by":"publisher","DOI":"10.1016\/S1473-3099(19)30275-0"},{"key":"e_1_3_2_34_2","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciz309"},{"key":"e_1_3_2_35_2","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0116207"},{"key":"e_1_3_2_36_2","doi-asserted-by":"publisher","DOI":"10.1542\/hpeds.2018-0193"}],"container-title":["Antimicrobial Agents and Chemotherapy"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/aac.00824-23","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/aac.00824-23","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,10,18]],"date-time":"2023-10-18T09:01:41Z","timestamp":1697619701000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.asm.org\/doi\/10.1128\/aac.00824-23"}},"subtitle":[],"editor":[{"given":"Cesar A.","family":"Arias","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"editor"}]}],"short-title":[],"issued":{"date-parts":[[2023,10,18]]},"references-count":34,"journal-issue":{"issue":"10","published-print":{"date-parts":[[2023,10,18]]}},"alternative-id":["10.1128\/aac.00824-23"],"URL":"https:\/\/doi.org\/10.1128\/aac.00824-23","relation":{},"ISSN":["0066-4804","1098-6596"],"issn-type":[{"value":"0066-4804","type":"print"},{"value":"1098-6596","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,10,18]]},"assertion":[{"value":"2023-06-22","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-07-13","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2023-09-28","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}],"article-number":"e00824-23"}}