{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,11,2]],"date-time":"2026-11-02T23:28:27Z","timestamp":1793662107617,"version":"4.5.1"},"reference-count":43,"publisher":"Oxford University Press (OUP)","issue":"1","license":[{"start":{"date-parts":[[2026,3,3]],"date-time":"2026-03-03T00:00:00Z","timestamp":1772496000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"name":"Paratek Pharmaceuticals, Inc"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2026,7,23]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Omadacycline is an FDA-approved oral and intravenous treatment for adults with community-acquired bacterial pneumonia and acute bacterial skin and skin structure infection that demonstrates potent in vitro activity and in vivo efficacy versus Mycobacterium abscessus.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>A randomized, double-blind, placebo-controlled, multicenter phase 2 study of omadacycline monotherapy was conducted in adults with nontuberculous mycobacterial pulmonary disease (NTM-PD) caused by M. abscessus. Eligible patients meeting the diagnostic criteria for NTM-PD were randomized 1.5:1 to receive omadacycline 300 mg orally once daily or placebo for 84 days. Randomization was stratified by prior antibiotic treatment for M. abscessus (yes\/no).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Sixty-six patients were randomized (41 omadacycline, 25 placebo). At baseline, cough, fatigue, mucus production, shortness of breath, and throat clearing were the most bothersome and common symptoms (68.2%\u201395.4% of patients). For the primary endpoint, 34.1% and 20.0% of omadacycline and placebo patients, respectively, were responders by definition 1 (improvement in symptom severity at day 84 for at least half of baseline symptoms) and 34.1% and 12.0%, respectively, were responders by definition 2 (definition 1 plus no deterioration in severity of any baseline symptom). Key secondary and exploratory clinical and microbiological endpoints also favored omadacycline compared with placebo. Four (9.8%) patients discontinued omadacycline therapy due to a treatment-emergent adverse event (TEAE). The most frequent omadacycline-related TEAEs were gastrointestinal, particularly nausea.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Results consistently favored omadacycline monotherapy over placebo across several endpoints in NTM-PD caused by M. abscessus. Omadacycline was well tolerated; nausea was the most frequent TEAE. Further investigations are warranted.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/cid\/ciag062","type":"journal-article","created":{"date-parts":[[2026,2,4]],"date-time":"2026-02-04T12:44:24Z","timestamp":1770209064000},"page":"e133-e142","source":"Crossref","is-referenced-by-count":5,"title":["Omadacycline Monotherapy in Nontuberculous Mycobacterial Pulmonary Disease Caused by\n                    <i>Mycobacterium abscessus<\/i>\n                    : Results From a Phase 2, Double-blind, Randomized, Placebo-controlled Study"],"prefix":"10.1093","volume":"83","author":[{"given":"Kevin L","family":"Winthrop","sequence":"first","affiliation":[{"name":"School of Public Health, Oregon Health & Science University\u2013Portland State University , Portland, Oregon ,","place":["USA"]},{"name":"Department of Medicine, Division of Infectious Diseases, Oregon Health & Science University , Portland, Oregon 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,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2351-6320","authenticated-orcid":false,"given":"Alisa W","family":"Serio","sequence":"additional","affiliation":[{"name":"Paratek Pharmaceuticals, Inc. , King of Prussia, Pennsylvania ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0008-9356-8223","authenticated-orcid":false,"given":"Diane M","family":"Anastasiou","sequence":"additional","affiliation":[{"name":"Paratek Pharmaceuticals, Inc. , King of Prussia, Pennsylvania ,","place":["USA"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen","family":"Villano","sequence":"additional","affiliation":[{"name":"Paratek Pharmaceuticals, Inc. , King of Prussia, Pennsylvania 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