{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,8,29]],"date-time":"2026-08-29T05:38:45Z","timestamp":1787981925473,"version":"build-2784847793"},"reference-count":55,"publisher":"Oxford University Press (OUP)","issue":"6","license":[{"start":{"date-parts":[[2022,3,8]],"date-time":"2022-03-08T00:00:00Z","timestamp":1646697600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Investigator Initiated Research","award":["2020-0008-Gumbo"],"award-info":[{"award-number":["2020-0008-Gumbo"]}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2022,5,29]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Objectives<\/jats:title>\n                  <jats:p>The standard of care (SOC) for the treatment of pulmonary Mycobacterium avium complex (MAC) disease (clarithromycin, rifabutin, and ethambutol) achieves sustained sputum conversion rates of only 54%. Thus, new treatments should be prioritized.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>We identified the omadacycline MIC against one laboratory MAC strain and calculated drug half life in solution, which we compared with measured MAC doubling times. Next, we performed an omadacycline hollow fibre system model of intracellular MAC (HFS-MAC) exposure\u2013effect study, as well as the three-drug SOC, using pharmacokinetics achieved in patient lung lesions. Data was analysed using bacterial kill slopes (\u03b3-slopes) and inhibitory sigmoid Emax bacterial burden versus exposure analyses. Monte Carlo experiments (MCE) were used to identify the optimal omadacycline clinical dose.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>Omadacycline concentration declined in solution with a half-life of 27.7\u2005h versus a MAC doubling time of 16.3\u2005h, leading to artefactually high MICs. Exposures mediating 80% of maximal effect changed up to 8-fold depending on sampling day with bacterial burden versus exposure analyses, while \u03b3-slope-based analyses gave a single robust estimate. The highest omadacycline monotherapy \u03b3-slope was \u22120.114 (95% CI: \u22120.141 to \u22120.087) (r2\u200a=\u200a0.98) versus \u22120.114 (95% CI: \u22120.133 to \u22120.094) (r2\u200a=\u200a0.99) with the SOC. MCEs demonstrated that 450\u2005mg of omadacycline given orally on the first 2\u2005days followed by 300\u2005mg daily would achieve the AUC0-24 target of 39.67\u2005mg\u00b7h\/L.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>Omadacycline may be a potential treatment option for pulmonary MAC, possibly as a back-bone treatment for a new MAC regimen and warrants future study in treatment of this disease.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/jac\/dkac068","type":"journal-article","created":{"date-parts":[[2022,2,22]],"date-time":"2022-02-22T20:14:50Z","timestamp":1645560890000},"page":"1694-1705","source":"Crossref","is-referenced-by-count":34,"title":["Omadacycline efficacy in the hollow fibre system model of pulmonary <i>Mycobacterium avium<\/i> complex and potency at clinically attainable doses"],"prefix":"10.1093","volume":"77","author":[{"given":"Moti","family":"Chapagain","sequence":"first","affiliation":[{"name":"Hollow Fiber System & Experimental Therapeutics Laboratory, Praedicare Inc. , 14830 Venture Drive, Dallas, Texas, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jotam G.","family":"Pasipanodya","sequence":"additional","affiliation":[{"name":"Quantitative Preclinical & Clinical Sciences Department, Praedicare Inc. , 14830 Venture Drive, Dallas, Texas, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shruti","family":"Athale","sequence":"additional","affiliation":[{"name":"Hollow Fiber System & Experimental Therapeutics Laboratory, Praedicare Inc. , 14830 Venture Drive, Dallas, Texas, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"suffix":"III","given":"Claude","family":"Bernal","sequence":"additional","affiliation":[{"name":"Praedicare Chemistry, Praedicare Inc. , 14830 Venture Drive, Dallas, Texas, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rachel","family":"Trammell","sequence":"additional","affiliation":[{"name":"Praedicare Chemistry, Praedicare Inc. , 14830 Venture Drive, Dallas, Texas, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Howe","sequence":"additional","affiliation":[{"name":"Hollow Fiber System & Experimental Therapeutics Laboratory, Praedicare Inc. , 14830 Venture Drive, Dallas, Texas, USA"},{"name":"Quantitative Preclinical & Clinical Sciences Department, Praedicare Inc. , 14830 Venture Drive, Dallas, Texas, USA"},{"name":"Praedicare Chemistry, Praedicare Inc. , 14830 Venture Drive, Dallas, Texas, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tawanda","family":"Gumbo","sequence":"additional","affiliation":[{"name":"Hollow Fiber System & Experimental Therapeutics Laboratory, Praedicare Inc. , 14830 Venture Drive, Dallas, Texas, USA"},{"name":"Quantitative Preclinical & Clinical Sciences Department, Praedicare Inc. , 14830 Venture Drive, Dallas, Texas, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2022,3,8]]},"reference":[{"key":"2022053122480283900_dkac068-B1","doi-asserted-by":"crossref","first-page":"e1","DOI":"10.1093\/cid\/ciaa241","article-title":"Treatment of nontuberculous mycobacterial pulmonary disease: An official ATS\/ERS\/ESCMID\/IDSA clinical practice guideline: Executive summary","volume":"71","author":"Daley","year":"2020","journal-title":"Clin Infect Dis"},{"key":"2022053122480283900_dkac068-B2","doi-asserted-by":"crossref","first-page":"i3","DOI":"10.1093\/jac\/dkx311","article-title":"Meta-analyses and the evidence base for microbial outcomes in the treatment of pulmonary Mycobacterium avium-intracellulare complex disease","volume":"72","author":"Pasipanodya","year":"2017","journal-title":"J Antimicrob Chemother"},{"key":"2022053122480283900_dkac068-B3","doi-asserted-by":"crossref","first-page":"276","DOI":"10.1378\/chest.13-2538","article-title":"Macrolide\/Azalide therapy for nodular\/bronchiectatic mycobacterium avium complex lung disease","volume":"146","author":"Wallace","year":"2014","journal-title":"Chest"},{"key":"2022053122480283900_dkac068-B4","doi-asserted-by":"crossref","first-page":"96","DOI":"10.1164\/rccm.201408-1545OC","article-title":"Intermittent antibiotic therapy for nodular bronchiectatic Mycobacterium avium complex lung disease","volume":"191","author":"Jeong","year":"2015","journal-title":"Am J Respir Crit Care Med"},{"key":"2022053122480283900_dkac068-B5","doi-asserted-by":"crossref","first-page":"220","DOI":"10.1016\/j.rmed.2017.08.031","article-title":"Treatment and outcome of non-tuberculous mycobacterial pulmonary disease in a predominantly fibro-cavitary disease cohort","volume":"131","author":"Zweijpfenning","year":"2017","journal-title":"Respir Med"},{"key":"2022053122480283900_dkac068-B6","article-title":"What is important for people with NTM? 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