{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,12,5]],"date-time":"2025-12-05T12:21:58Z","timestamp":1764937318822,"version":"3.37.3"},"reference-count":22,"publisher":"Oxford University Press (OUP)","issue":"1","license":[{"start":{"date-parts":[[2021,10,6]],"date-time":"2021-10-06T00:00:00Z","timestamp":1633478400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/academic.oup.com\/journals\/pages\/open_access\/funder_policies\/chorus\/standard_publication_model"}],"funder":[{"name":"Theravance Biopharma, Inc"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2021,12,24]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background<\/jats:title><jats:p>Telavancin is a lipoglycopeptide antibiotic with limited pharmacokinetic data to guide drug dosing in patients receiving haemodialysis.<\/jats:p><\/jats:sec><jats:sec><jats:title>Objectives<\/jats:title><jats:p>This study characterized telavancin pharmacokinetics in patients receiving haemodialysis.<\/jats:p><\/jats:sec><jats:sec><jats:title>Patients and methods<\/jats:title><jats:p>This was a Phase IV, prospective, open-label, single-centre, crossover pharmacokinetic study (ClinicalTrials.gov: NCT02392208). Eight subjects with end-stage kidney disease requiring maintenance haemodialysis (mean\u200a\u00b1\u200aSD: 47\u200a\u00b1\u200a20\u2009years, 69.5\u200a\u00b1\u200a17.1\u2009kg) received 5\u2009mg\/kg telavancin IV 3\u2009h before starting a 3.5\u2009hour haemodialysis treatment with a high-permeability haemodialyser (haemodialysis period). After a 14\u2009day washout period, a second 5\u2009mg\/kg dose was administered post-haemodialysis (control period). Telavancin plasma concentrations were measured over a 2\u2009day period after each dose and non-compartmental pharmacokinetic analyses were performed.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The geometric mean (GM) of telavancin overall clearance was 11.2\u2009mL\/h\/kg (intrinsic clearance and dialytic clearance) in the haemodialysis period and 5.9\u2009mL\/h\/kg (off-haemodialysis clearance) in the control period [GM ratio (GMR)\u200a=\u200a1.89; 90% CI: 1.70\u20132.10; P\u200a&amp;lt;\u200a0.01]. The GM t\u00bd was 13.1\u2009h when haemodialysis occurred 3\u2009h post-dosing in the haemodialysis period but extended to 20.9\u2009h with post-haemodialysis dosing in the control period (GMR\u200a=\u200a0.63; 90% CI: 0.54\u20130.73; P\u200a&amp;lt;\u200a0.01). The GM of telavancin plasma concentrations removed by haemodialysis was 27.7%. The GMR of peak plasma concentration and volume of distribution of the haemodialysis period and the control period were 0.88\u2009(90% CI: 0.79\u20130.98; P\u200a=\u200a0.08) and 1.17 (90% CI: 1.05\u20131.30; P\u200a=\u200a0.048), respectively.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Haemodialysis with high-permeability haemodialysers removes telavancin considerably (\u223c\u2153 of body load). Telavancin 5\u2009mg\/kg every 48\u2009h post-haemodialysis dosing is recommended, but dose adjustments may be warranted if haemodialysis starts within 3\u2009h of telavancin administration.<\/jats:p><\/jats:sec>","DOI":"10.1093\/jac\/dkab370","type":"journal-article","created":{"date-parts":[[2021,9,17]],"date-time":"2021-09-17T19:12:37Z","timestamp":1631905957000},"page":"174-180","source":"Crossref","is-referenced-by-count":3,"title":["Telavancin pharmacokinetics in patients with chronic kidney disease receiving haemodialysis"],"prefix":"10.1093","volume":"77","author":[{"given":"Katherine N","family":"Gharibian","sequence":"first","affiliation":[{"name":"Amgen, Thousand Oaks, CA, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9876-2948","authenticated-orcid":false,"given":"Susan J","family":"Lewis","sequence":"additional","affiliation":[{"name":"Department of Pharmacy Practice, University of Findlay College of Pharmacy, Findlay, OH, USA"},{"name":"Department of Pharmacy, Mercy Health St. Anne Hospital, Toledo, OH, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Michael","family":"Heung","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, University of Michigan School of Medicine, Ann Arbor, MI, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jonathan H","family":"Segal","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, University of Michigan School of Medicine, Ann Arbor, MI, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Noha N","family":"Salama","sequence":"additional","affiliation":[{"name":"Department of Pharmaceutics and Industrial Pharmacy, Cairo University Faculty of Pharmacy, Cairo, Egypt"},{"name":"Department of Pharmaceutical and Administrative Sciences, St. Louis College of Pharmacy at the University of Health Sciences and Pharmacy, St. Louis, MO, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Bruce A","family":"Mueller","sequence":"additional","affiliation":[{"name":"Department of Clinical Pharmacy, University of Michigan College of Pharmacy, Ann Arbor, MI, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"286","published-online":{"date-parts":[[2021,10,6]]},"reference":[{"key":"2022010520152313400_dkab370-B1"},{"key":"2022010520152313400_dkab370-B2","doi-asserted-by":"crossref","first-page":"326","DOI":"10.1016\/S0272-6386(12)80091-6","article-title":"Mortality in dialysis patients: analysis of the causes of death","volume":"18","author":"Mailloux","year":"1991","journal-title":"Am J Kidney Dis"},{"key":"2022010520152313400_dkab370-B3","doi-asserted-by":"crossref","first-page":"1388","DOI":"10.2215\/CJN.01590309","article-title":"Staphylococcus aureus infections in haemodialysis: what a nephrologist should know","volume":"4","author":"Vandecasteele","year":"2009","journal-title":"Clin J Am Soc Nephrol"},{"key":"2022010520152313400_dkab370-B4","doi-asserted-by":"crossref","first-page":"869","DOI":"10.1681\/ASN.V95869","article-title":"EPIBACDIAL: a multicenter prospective study of risk factors for bacteremia in chronic hemodialysis patients","volume":"9","author":"Hoen","year":"1998","journal-title":"J Am Soc Nephrol"},{"key":"2022010520152313400_dkab370-B5","doi-asserted-by":"crossref","first-page":"56","DOI":"10.1111\/j.1542-4758.2006.01175.x","article-title":"Mortality differences among organisms causing septicemia in hemodialysis patients","volume":"10","author":"Danese","year":"2006","journal-title":"Hemodial Int"},{"key":"2022010520152313400_dkab370-B6","doi-asserted-by":"crossref","first-page":"e0136082","DOI":"10.1371\/journal.pone.0136082","article-title":"Systematic review and meta-analysis of the epidemiology of vancomycin-intermediate and heterogeneous vancomycin-intermediate Staphylococcus aureus isolates","volume":"10","author":"Zhang","year":"2015","journal-title":"PLoS One"},{"key":"2022010520152313400_dkab370-B7","doi-asserted-by":"crossref","first-page":"1208","DOI":"10.1016\/j.clinthera.2006.08.003","article-title":"Case-control study of the relationship between MRSA bacteremia with a vancomycin MIC of 2 \u03bcg\/mL and risk factors, costs, and outcomes in inpatients undergoing hemodialysis","volume":"28","author":"Maclayton","year":"2006","journal-title":"Clin Ther"},{"key":"2022010520152313400_dkab370-B8","doi-asserted-by":"crossref","first-page":"725","DOI":"10.1093\/jac\/dkq028","article-title":"Activity of telavancin against heterogeneous vancomycin-intermediate Staphylococcus aureus (hVISA) in vitro and in an in vivo mouse model of bacteraemia","volume":"65","author":"Hegde","year":"2010","journal-title":"J Antimicrob Chemother"},{"key":"2022010520152313400_dkab370-B9","doi-asserted-by":"crossref","first-page":"275","DOI":"10.1016\/j.diagmicrobio.2014.12.011","article-title":"Update of the telavancin activity in vitro tested against a worldwide collection of Gram-positive clinical isolates (2013), when applying the revised susceptibility testing method","volume":"81","author":"Mendes","year":"2015","journal-title":"Diagn Microbiol Infect Dis"},{"key":"2022010520152313400_dkab370-B10","doi-asserted-by":"crossref","first-page":"3311","DOI":"10.1128\/AAC.01470-06","article-title":"Pharmacodynamic effects of telavancin against methicillin-resistant and methicillin-susceptible Staphylococcus aureus strains in the presence of human albumin or serum and in an in vitro kinetic model","volume":"51","author":"Odenholt","year":"2007","journal-title":"Antimicrob Agents Chemother"},{"key":"2022010520152313400_dkab370-B11","doi-asserted-by":"crossref","first-page":"e00281-17","DOI":"10.1128\/AAC.00281-17","article-title":"Comparative pharmacodynamics of telavancin and vancomycin in the neutropenic murine thigh and lung infection models against Staphylococcus aureus","volume":"61","author":"Lepak","year":"2017","journal-title":"Antimicrob Agents Chemother"},{"key":"2022010520152313400_dkab370-B12","doi-asserted-by":"crossref","first-page":"3365","DOI":"10.1128\/AAC.01750-09","article-title":"Mass balance and pharmacokinetics of [14C]telavancin following intravenous administration to healthy male volunteers","volume":"54","author":"Shaw","year":"2010","journal-title":"Antimicrob Agents Chemother"},{"key":"2022010520152313400_dkab370-B13"},{"key":"2022010520152313400_dkab370-B14","doi-asserted-by":"crossref","first-page":"707","DOI":"10.1007\/s00228-015-1847-6","article-title":"Pharmacokinetics of intravenous telavancin in healthy subjects with varying degrees of renal impairment","volume":"71","author":"Worboys","year":"2015","journal-title":"Eur J Clin Pharmacol"},{"key":"2022010520152313400_dkab370-B15","doi-asserted-by":"crossref","first-page":"2062","DOI":"10.1128\/AAC.00383-11","article-title":"Telavancin pharmacokinetics and pharmacodynamics in patients with complicated skin and skin structure infections and various degrees of renal function","volume":"56","author":"Lodise","year":"2012","journal-title":"Antimicrob Agents Chemother"},{"key":"2022010520152313400_dkab370-B16","doi-asserted-by":"crossref","first-page":"764","DOI":"10.1093\/jac\/dkx437","article-title":"Telavancin for refractory MRSA bacteraemia in intermittent haemodialysis recipients","volume":"73","author":"Britt","year":"2018","journal-title":"J Antimicrob Chemother"},{"key":"2022010520152313400_dkab370-B17","doi-asserted-by":"crossref","first-page":"1205","DOI":"10.1681\/ASN.V451205","article-title":"Second generation logarithmic estimates of single-pool variable volume Kt\/V: an analysis of error","volume":"4","author":"Daugirdas","year":"1993","journal-title":"J Am Soc Nephrol"},{"key":"2022010520152313400_dkab370-B18","doi-asserted-by":"crossref","first-page":"1190","DOI":"10.2215\/CJN.01650309","article-title":"Intradialytic administration of daptomycin in end stage renal disease patients on hemodialysis","volume":"4","author":"Salama","year":"2009","journal-title":"Clin J Am Soc Nephrol"},{"key":"2022010520152313400_dkab370-B19","doi-asserted-by":"crossref","first-page":"256","DOI":"10.1002\/j.1875-9114.1997.tb03707.x","article-title":"Effects of dialysis membrane on intradialytic vancomycin administration","volume":"17","author":"Scott","year":"1997","journal-title":"Pharmacotherapy"},{"key":"2022010520152313400_dkab370-B20","doi-asserted-by":"crossref","first-page":"867","DOI":"10.1128\/AAC.00933-10","article-title":"Pharmacodynamics of telavancin studied in an in vitro pharmacokinetic model of infection","volume":"55","author":"MacGowan","year":"2011","journal-title":"Antimicrob Agents Chemother"},{"key":"2022010520152313400_dkab370-B21","doi-asserted-by":"crossref","first-page":"461","DOI":"10.1016\/0002-9343(77)90397-7","article-title":"Pharmacokinetics in renal disease","volume":"62","author":"Levy","year":"1977","journal-title":"Am J Med"},{"key":"2022010520152313400_dkab370-B22","doi-asserted-by":"crossref","first-page":"S7","DOI":"10.1016\/S0272-6386(01)70005-4","article-title":"NKF-K\/DOQI clinical practice guidelines for hemodialysis adequacy: update 2000","volume":"37","year":"2001","journal-title":"Am J Kidney Dis"}],"container-title":["Journal of Antimicrobial Chemotherapy"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/academic.oup.com\/jac\/article-pdf\/77\/1\/174\/41931314\/dkab370.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"syndication"},{"URL":"https:\/\/academic.oup.com\/jac\/article-pdf\/77\/1\/174\/41931314\/dkab370.pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2023,11,9]],"date-time":"2023-11-09T00:04:10Z","timestamp":1699488250000},"score":1,"resource":{"primary":{"URL":"https:\/\/academic.oup.com\/jac\/article\/77\/1\/174\/6382244"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,10,6]]},"references-count":22,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2021,10,6]]},"published-print":{"date-parts":[[2021,12,24]]}},"URL":"https:\/\/doi.org\/10.1093\/jac\/dkab370","relation":{},"ISSN":["0305-7453","1460-2091"],"issn-type":[{"type":"print","value":"0305-7453"},{"type":"electronic","value":"1460-2091"}],"subject":[],"published-other":{"date-parts":[[2022,1,1]]},"published":{"date-parts":[[2021,10,6]]}}}