{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,31]],"date-time":"2026-07-31T15:12:19Z","timestamp":1785510739086,"version":"3.56.0"},"reference-count":30,"publisher":"American Society for Microbiology","issue":"2","license":[{"start":{"date-parts":[[2018,1,25]],"date-time":"2018-01-25T00:00:00Z","timestamp":1516838400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2018,2,1]],"date-time":"2018-02-01T00:00:00Z","timestamp":1517443200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/journals.asm.org\/non-commercial-tdm-license"}],"content-domain":{"domain":["journals.asm.org"],"crossmark-restriction":true},"short-container-title":["Antimicrob Agents Chemother"],"published-print":{"date-parts":[[2018,2]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n          <jats:p>\n            Many antibiotics require dose adjustments in patients with renal impairment and\/or in those undergoing hemodialysis. Omadacycline, the first aminomethylcycline antibiotic in late-stage clinical development, displays activity against a broad spectrum of bacterial pathogens, including drug-resistant strains. Data from completed phase 3 studies of omadacycline for the treatment of acute bacterial skin and skin structure infections (ABSSSI) and community-acquired bacterial pneumonia (CABP) showed intravenous (i.v.) to once-daily oral omadacycline to be clinically effective and well tolerated. To determine if the dosing of omadacycline should be adjusted in patients with impaired renal function, a phase 1 study examining the pharmacokinetics (PK) and safety of i.v. omadacycline (100 mg) was conducted in subjects with end-stage renal disease (ESRD) on stable hemodialysis (\n            <jats:italic>n<\/jats:italic>\n            = 8) and in matched healthy subjects (\n            <jats:italic>n<\/jats:italic>\n            = 8). i.v. administration of omadacycline produced similar plasma concentration-time profiles in subjects with ESRD and healthy subjects. Further, in subjects with ESRD, similar values of the PK parameters were observed when omadacycline was administered i.v. after or before dialysis. The mean area under the concentration-time curve from time zero extrapolated to infinity in plasma was 10.30 \u03bcg \u00b7 h\/ml when omadacycline was administered to ESRD subjects after dialysis, 10.20 \u03bcg \u00b7 h\/ml when omadacycline was administered to ESRD subjects before dialysis, and 9.76 \u03bcg \u00b7 h\/ml when omadacycline was administered to healthy subjects. The mean maximum observed concentration of omadacycline in plasma in ESRD subjects was 1.88 \u03bcg\/ml when it was administered after dialysis and 2.33 \u03bcg\/ml when it was administered before dialysis, and in healthy subjects it was 1.92 \u03bcg\/ml. The 100-mg i.v. dose of omadacycline was generally safe and well tolerated in both ESRD and healthy subjects. This study demonstrates that no dose adjustment is necessary for omadacycline in patients with impaired renal function or on days when patients are receiving hemodialysis.\n          <\/jats:p>","DOI":"10.1128\/aac.02057-17","type":"journal-article","created":{"date-parts":[[2017,11,20]],"date-time":"2017-11-20T17:10:26Z","timestamp":1511197826000},"update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":41,"title":["Pharmacokinetics and Safety of Omadacycline in Subjects with Impaired Renal Function"],"prefix":"10.1128","volume":"62","author":[{"given":"Jolene K.","family":"Berg","sequence":"first","affiliation":[{"name":"DaVita Clinical Research, Minneapolis, Minnesota, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Evan","family":"Tzanis","sequence":"additional","affiliation":[{"name":"Paratek Pharmaceuticals Inc., King of Prussia, Pennsylvania, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lynne","family":"Garrity-Ryan","sequence":"additional","affiliation":[{"name":"Paratek Pharmaceuticals Inc., King of Prussia, Pennsylvania, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen","family":"Bai","sequence":"additional","affiliation":[{"name":"Paratek Pharmaceuticals Inc., King of Prussia, Pennsylvania, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Surya","family":"Chitra","sequence":"additional","affiliation":[{"name":"Paratek Pharmaceuticals Inc., King of Prussia, Pennsylvania, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Amy","family":"Manley","sequence":"additional","affiliation":[{"name":"Paratek Pharmaceuticals Inc., King of Prussia, Pennsylvania, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen","family":"Villano","sequence":"additional","affiliation":[{"name":"Paratek Pharmaceuticals Inc., King of Prussia, Pennsylvania, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"235","reference":[{"key":"e_1_3_2_2_2","volume-title":"2016 USRDS annual data report: epidemiology of kidney disease in the United States","author":"U.S. Renal Data System","year":"2016","unstructured":"U.S. Renal Data System. 2016. 2016 USRDS annual data report: epidemiology of kidney disease in the United States. National Institutes of Health, Bethesda, MD."},{"key":"e_1_3_2_3_2","doi-asserted-by":"publisher","DOI":"10.1097\/MD.0000000000000174"},{"key":"e_1_3_2_4_2","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pone.0143276"},{"key":"e_1_3_2_5_2","doi-asserted-by":"publisher","DOI":"10.1164\/ajrccm.160.2.9808045"},{"key":"e_1_3_2_6_2","doi-asserted-by":"publisher","DOI":"10.2215\/CJN.05980809"},{"key":"e_1_3_2_7_2","doi-asserted-by":"publisher","DOI":"10.2217\/fmb-2016-0100"},{"key":"e_1_3_2_8_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.01536-15"},{"key":"e_1_3_2_9_2","doi-asserted-by":"publisher","DOI":"10.1128\/MMBR.65.2.232-260.2001"},{"key":"e_1_3_2_10_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.01066-13"},{"key":"e_1_3_2_11_2","volume-title":"Abstr 27th Eur Congr Clin Microbiol Infect Dis (ECCMID)","author":"O'Riordan WA","year":"2017","unstructured":"O'Riordan WA, Green S, Overcash JS, Pulijiz I, Metallidis S, Gardovskis J, Garrity-Ryan L, Das A, Tzanis E, Eckburg P, Manley A, Villano S, Loh E. 2017. A phase 3 randomized, double-blind, multi-center study to compare the safety and efficacy of oral and i.v. omadacycline to linezolid for treating adult subjects with ABSSSI (the OASIS study), abstr 630. Abstr 27th Eur Congr Clin Microbiol Infect Dis (ECCMID), Vienna, Austria."},{"key":"e_1_3_2_12_2","volume-title":"Press release","author":"Globe Newswire","year":"2017","unstructured":"Globe Newswire. 3 April 2017. Paratek announces positive phase 3 study of omadacycline in community-acquired bacterial pneumonia. Press release. Globe Newswire, Boston, MA."},{"key":"e_1_3_2_13_2","volume-title":"Press release","author":"Globe Newswire","year":"2017","unstructured":"Globe Newswire. 17 July 2017. Paratek announces phase 3 study of oral-only dosing of omadacycline met all primary and secondary FDA and EMA efficacy endpoints in acute bacterial skin infections. Press release. 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