{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,25]],"date-time":"2026-09-25T05:40:23Z","timestamp":1790314823798,"version":"4.1.0"},"reference-count":42,"publisher":"Oxford University Press (OUP)","issue":"Supplement_1","license":[{"start":{"date-parts":[[2019,8,1]],"date-time":"2019-08-01T00:00:00Z","timestamp":1564617600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2019,8,1]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p>When tetracyclines were introduced in the 1940s, these antibiotics offered a broad spectrum of activity against multiple types of pathogens. However, their utility waned after the selection of tetracycline resistance in the pathogens against which they were effective. Omadacycline is a semisynthetic aminomethylcycline antibacterial derived from the tetracycline class of antibiotics that is unaffected by these resistance mechanisms. It has an appropriate spectrum of activity for community-acquired infections, including those caused by many resistant organisms. Omadacycline offers a well-tolerated treatment for acute bacterial skin and skin structure infections and community-acquired bacterial pneumonia. Omadacycline has minimal known drug\u2013drug interactions, and should be administered in a fasting state, avoiding dairy and cation-containing products for at least 4 hours after dosing. It does not require dose adjustments for sex, age, or hepatic or renal impairment, and has a safety profile similar to that of other oral tetracyclines. Because omadacycline can be administered effectively orally, it can help reduce hospitalization costs associated with intravenous antibiotic administration. This special supplement to Clinical Infectious Diseases offers an in-depth examination of omadacycline development, including discussions of pharmacokinetic and pharmacodynamic trials, spectrum of activity and preclinical data, early clinical trials, phase III clinical trials, and an integrated safety summary.<\/jats:p>","DOI":"10.1093\/cid\/ciz394","type":"journal-article","created":{"date-parts":[[2019,5,13]],"date-time":"2019-05-13T19:13:24Z","timestamp":1557774804000},"page":"S1-S5","source":"Crossref","is-referenced-by-count":56,"title":["Omadacycline: A Modernized Tetracycline"],"prefix":"10.1093","volume":"69","author":[{"given":"Jason C","family":"Gallagher","sequence":"first","affiliation":[{"name":"Temple University School of Pharmacy, Philadelphia, Pennsylvania"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2019,8,1]]},"reference":[{"key":"2019080101102246100_CIT0001","doi-asserted-by":"crossref","first-page":"17","DOI":"10.1111\/j.1749-6632.2011.06354.x","article-title":"The history of the tetracyclines","volume":"1241","author":"Nelson","year":"2011","journal-title":"Ann N Y Acad Sci"},{"key":"2019080101102246100_CIT0002","doi-asserted-by":"crossref","first-page":"7044","DOI":"10.1128\/AAC.01536-15","article-title":"Structure-activity relationship of the aminomethylcyclines and the discovery of omadacycline","volume":"59","author":"Honeyman","year":"2015","journal-title":"Antimicrob Agents Chemother"},{"key":"2019080101102246100_CIT0003","doi-asserted-by":"crossref","first-page":"518","DOI":"10.1086\/505494","article-title":"Tigecycline: a critical analysis","volume":"43","author":"Stein","year":"2006","journal-title":"Clin Infect Dis"},{"key":"2019080101102246100_CIT0004","doi-asserted-by":"crossref","first-page":"1279","DOI":"10.1128\/AAC.01066-13","article-title":"Mechanism of action of the novel aminomethylcycline antibiotic omadacycline","volume":"58","author":"Draper","year":"2014","journal-title":"Antimicrob Agents Chemother"},{"key":"2019080101102246100_CIT0005","doi-asserted-by":"crossref","first-page":"1421","DOI":"10.2217\/fmb-2016-0100","article-title":"Omadacycline: development of a novel aminomethylcycline antibiotic for treating drug-resistant bacterial infections","volume":"11","author":"Villano","year":"2016","journal-title":"Future Microbiol"},{"key":"2019080101102246100_CIT0006","doi-asserted-by":"crossref","first-page":"1127","DOI":"10.1128\/AAC.01242-13","article-title":"In vitro and in vivo antibacterial activities of omadacycline, a novel aminomethylcycline","volume":"58","author":"Macone","year":"2014","journal-title":"Antimicrob Agents Chemother"},{"key":"2019080101102246100_CIT0007","doi-asserted-by":"crossref","first-page":"682","DOI":"10.1080\/00498254.2016.1213465","article-title":"Clinical disposition, metabolism and in vitro drug-drug interaction properties of omadacycline","volume":"47","author":"Flarakos","year":"2017","journal-title":"Xenobiotica"},{"key":"2019080101102246100_CIT0008","doi-asserted-by":"crossref","first-page":"895","DOI":"10.1086\/656431","article-title":"Skin and soft-tissue infections requiring hospitalization at an academic medical center: opportunities for antimicrobial stewardship","volume":"51","author":"Jenkins","year":"2010","journal-title":"Clin Infect Dis"},{"key":"2019080101102246100_CIT0009","doi-asserted-by":"crossref","first-page":"1182","DOI":"10.1016\/j.clinthera.2017.04.009","article-title":"The pharmacokinetics of the CYP3A substrate midazolam after steady-state dosing of delafloxacin","volume":"39","author":"Paulson","year":"2017","journal-title":"Clin Ther"},{"key":"2019080101102246100_CIT0010","author":"US Food and Drug Administration"},{"key":"2019080101102246100_CIT0011","doi-asserted-by":"crossref","first-page":"148","DOI":"10.1097\/QCO.0000000000000429","article-title":"The role of omadacycline in skin and soft tissue infections","volume":"31","author":"Montravers","year":"2018","journal-title":"Curr Opin Infect Dis"},{"key":"2019080101102246100_CIT0012","first-page":"1299","article-title":"Diagnosis and management of community-acquired pneumonia in adults","volume":"83","author":"Watkins","year":"2011","journal-title":"Am Fam Physician"},{"key":"2019080101102246100_CIT0013","doi-asserted-by":"crossref","first-page":"353","DOI":"10.4088\/PCC.09r00853","article-title":"Linezolid and serotonin syndrome","volume":"11","author":"Quinn","year":"2009","journal-title":"Prim Care Companion J Clin Psychiatry"},{"key":"2019080101102246100_CIT0014","first-page":"474","article-title":"Skin and soft tissue infections","volume":"92","author":"Ramakrishnan","year":"2015","journal-title":"Am Fam Physician"},{"key":"2019080101102246100_CIT0015","doi-asserted-by":"crossref","first-page":"1039","DOI":"10.1080\/17512433.2016.1195683","article-title":"Transitions of care in the management of acute bacterial skin and skin structure infections: a paradigm shift","volume":"9","author":"Verastegui","year":"2016","journal-title":"Expert Rev Clin Pharmacol"},{"key":"2019080101102246100_CIT0016","doi-asserted-by":"crossref","first-page":"296","DOI":"10.1186\/1471-2334-14-296","article-title":"Incidence and cost of hospitalizations associated with Staphylococcus aureus skin and soft tissue infections in the United States from 2001 through 2009","volume":"14","author":"Suaya","year":"2014","journal-title":"BMC Infect Dis"},{"key":"2019080101102246100_CIT0017","doi-asserted-by":"crossref","first-page":"S33","DOI":"10.1016\/j.cmi.2015.01.011","article-title":"Comparison of vancomycin and linezolid in patients with peripheral vascular disease and\/or diabetes in an observational European study of complicated skin and soft-tissue infections due to methicillin-resistant Staphylococcus aureus","volume":"21","author":"Eckmann","year":"2015","journal-title":"Clin Microbiol Infect"},{"key":"2019080101102246100_CIT0018","doi-asserted-by":"crossref","first-page":"1096","DOI":"10.3855\/jidc.4745","article-title":"High cost burden and health consequences of antibiotic resistance: the price to pay","volume":"8","author":"Chandy","year":"2014","journal-title":"J Infect Dev Ctries"},{"key":"2019080101102246100_CIT0019","doi-asserted-by":"crossref","first-page":"1162","DOI":"10.1093\/jac\/dkn073","article-title":"Treatment costs associated with community-acquired pneumonia by community level of antimicrobial resistance","volume":"61","author":"Asche","year":"2008","journal-title":"J Antimicrob Chemother"},{"key":"2019080101102246100_CIT0020","doi-asserted-by":"crossref","first-page":"S27","DOI":"10.1016\/S1198-743X(16)30095-7","article-title":"Current and future trends in antibiotic therapy of acute bacterial skin and skin-structure infections","volume":"22","author":"Russo","year":"2016","journal-title":"Clin Microbiol Infect"},{"key":"2019080101102246100_CIT0021","doi-asserted-by":"crossref","first-page":"1092","DOI":"10.3111\/13696998.2015.1078339","article-title":"Assessing the economic value of avoiding hospital admissions by shifting the management of gram+ acute bacterial skin and skin-structure infections to an outpatient care setting","volume":"18","author":"Ektare","year":"2015","journal-title":"J Med Econ"},{"key":"2019080101102246100_CIT0022","doi-asserted-by":"crossref","first-page":"730","DOI":"10.3111\/13696998.2014.941065","article-title":"Modeling economic implications of alternative treatment strategies for acute bacterial skin and skin structure infections","volume":"17","author":"Revankar","year":"2014","journal-title":"J Med Econ"},{"key":"2019080101102246100_CIT0023","doi-asserted-by":"crossref","first-page":"7502","DOI":"10.1128\/AAC.01734-16","article-title":"In vitro activities of omadacycline (PTK 0796) and other antimicrobial agents against human mycoplasmas and ureaplasmas","volume":"60","author":"Waites","year":"2016","journal-title":"Antimicrob Agents Chemother"},{"key":"2019080101102246100_CIT0024","doi-asserted-by":"crossref","DOI":"10.1128\/AAC.02368-16","article-title":"In vivo pharmacodynamic evaluation of omadacycline (PTK 0796) against Streptococcus pneumoniae in the murine pneumonia model","volume":"61","author":"Lepak","year":"2017","journal-title":"Antimicrob Agents Chemother"},{"issue":"Suppl 1","key":"2019080101102246100_CIT0025","doi-asserted-by":"crossref","first-page":"S6","DOI":"10.1093\/cid\/ciz395","article-title":"Microbiology and non-clinical review of omadacycline","volume":"69","author":"Karlowsky","year":"2019","journal-title":"Clin Infect Dis"},{"key":"2019080101102246100_CIT0026","doi-asserted-by":"crossref","first-page":"7431","DOI":"10.1128\/AAC.01393-16","article-title":"Randomized, open-label study of the pharmacokinetics and safety of oral and intravenous administration of omadacycline to healthy subjects","volume":"60","author":"Sun","year":"2016","journal-title":"Antimicrob Agents Chemother"},{"key":"2019080101102246100_CIT0027","doi-asserted-by":"crossref","first-page":"321","DOI":"10.1002\/jcph.814","article-title":"Effect of food on the bioavailability of omadacycline in healthy participants","volume":"57","author":"Tzanis","year":"2017","journal-title":"J Clin Pharmacol"},{"key":"2019080101102246100_CIT0028","doi-asserted-by":"crossref","DOI":"10.1128\/AAC.01135-17","article-title":"Comparison of omadacycline and tigecycline pharmacokinetics in the plasma, epithelial lining fluid, and alveolar cells of healthy adult subjects","volume":"61","author":"Gotfried","year":"2017","journal-title":"Antimicrob Agents Chemother"},{"key":"2019080101102246100_CIT0029","unstructured":"Tanaka SK , TzanisE, VillanoS. Effect of age and gender on the pharmacokinetics of oral and IV omadacycline, a new class of aminomethylcyclines. In: 26th European Congress of Clinical Microbiology and Infectious Diseases,Amsterdam, the Netherlands, 2016:1318."},{"key":"2019080101102246100_CIT0030","unstructured":"van Wart SA , ManleyA, BhavnaniSM, et al Population pharmacokinetics of omadacycline following intravenous or oral administration to phase 1 subjects. In: 26th European Congress of Clinical Microbiology and Infectious Diseases.Amsterdam, the Netherlands, 2016:P1320."},{"key":"2019080101102246100_CIT0031","unstructured":"Ting L , KovacsSJ, PraestgaardJ, et al Pharmacokinetics of omadacycline (PTK0796) in subjects with hepatic impairment. In: 52nd Annual Interscience Conference of Antimicrobial Agents and Chemotherapy,San Francisco, CA,2012:1282."},{"key":"2019080101102246100_CIT0032","doi-asserted-by":"crossref","DOI":"10.1128\/AAC.02057-17","article-title":"Pharmacokinetics and safety of omadacycline in subjects with impaired renal function","volume":"62","author":"Berg","year":"2018","journal-title":"Antimicrob Agents Chemother"},{"issue":"Suppl 1","key":"2019080101102246100_CIT0033","doi-asserted-by":"crossref","first-page":"S16","DOI":"10.1093\/cid\/ciz309","article-title":"Pharmacokinetics and pharmacodynamics of oral and intravenous omadacycline","volume":"69","author":"Rodvold","year":"2019","journal-title":"Clin Infect Dis"},{"key":"2019080101102246100_CIT0034","doi-asserted-by":"crossref","first-page":"528","DOI":"10.1056\/NEJMoa1800170","article-title":"Omadacycline for acute bacterial skin and skin-structure infections","volume":"380","author":"O\u2019Riordan","year":"2019","journal-title":"N Engl J Med"},{"key":"2019080101102246100_CIT0035","unstructured":"O\u2019Riordan W , CardenasC, SirbuA, et al A phase 3 randomized, double-blind, multi-centre study to compare the safety and efficacy of oral omadacycline to oral linezolid for treating adult subjects with ABSSSI (OASIS-2 study). In: 28th European Congress of Clinical Microbiology and Infectious Diseases, Madrid, Spain, 21\u201324 April 2018."},{"key":"2019080101102246100_CIT0036","doi-asserted-by":"crossref","first-page":"517","DOI":"10.1056\/NEJMoa1800201","article-title":"Omadacycline for community-acquired bacterial pneumonia","volume":"380","author":"Stets","year":"2019","journal-title":"N Engl J Med"},{"key":"2019080101102246100_CIT0037","volume-title":"Guidance for industry community-acquired bacterial pneumonia: developing drugs for treatment","author":"US Food and Drug Administration","year":"2014"},{"key":"2019080101102246100_CIT0038","doi-asserted-by":"crossref","first-page":"603","DOI":"10.1093\/cid\/civ927","article-title":"Developing outcomes assessments as endpoints for registrational clinical trials of antibacterial drugs: 2015 update from the biomarkers consortium of the Foundation for the National Institutes of Health","volume":"62","author":"Talbot","year":"2016","journal-title":"Clin Infect Dis"},{"issue":"Suppl 1","key":"2019080101102246100_CIT0039","doi-asserted-by":"crossref","first-page":"S23","DOI":"10.1093\/cid\/ciz396","article-title":"Omadacycline for acute bacterial skin and skin structure infection","volume":"69","author":"Abrahamian","year":"2019","journal-title":"Clin Infect Dis"},{"issue":"Suppl 1","key":"2019080101102246100_CIT0040","doi-asserted-by":"crossref","first-page":"S33","DOI":"10.1093\/cid\/ciz397","article-title":"Early clinical response in community-acquired bacterial pneumonia: from clinical endpoint to clinical practice","volume":"69","author":"Ramirez","year":"2019","journal-title":"Clin Infect Dis"},{"key":"2019080101102246100_CIT0041","doi-asserted-by":"crossref","unstructured":"Villano S , TanakaSK. Omadacycline, an aminomethylcycline antibiotic, has no effect on QT\/QTc intervals in healthy subjects. In: 26th European Congress of Clinical Microbiology and Infectious Diseases,Amsterdam, Netherlands, 9\u201312 April 2016.","DOI":"10.26226\/morressier.56d6be7ad462b80296c97dd7"},{"issue":"Suppl 1","key":"2019080101102246100_CIT0042","doi-asserted-by":"crossref","first-page":"S40","DOI":"10.1093\/cid\/ciz398","article-title":"An integrated safety summary of the novel aminomethylcycline antibiotic omadacycline","volume":"69","author":"Opal","year":"2019","journal-title":"Clin Infect Dis"}],"container-title":["Clinical Infectious Diseases"],"original-title":[],"language":"en","link":[{"URL":"http:\/\/academic.oup.com\/cid\/article-pdf\/69\/Supplement_1\/S1\/29021838\/ciz394.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,9,17]],"date-time":"2022-09-17T23:29:15Z","timestamp":1663457355000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/cid\/article\/69\/Supplement_1\/S1\/5541766"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2019,8,1]]},"references-count":42,"journal-issue":{"issue":"Supplement_1","published-online":{"date-parts":[[2019,8,1]]},"published-print":{"date-parts":[[2019,8,1]]}},"URL":"https:\/\/doi.org\/10.1093\/cid\/ciz394","relation":{},"ISSN":["1058-4838","1537-6591"],"issn-type":[{"value":"1058-4838","type":"print"},{"value":"1537-6591","type":"electronic"}],"subject":[],"published-other":{"date-parts":[[2019,8,15]]},"published":{"date-parts":[[2019,8,1]]}}}