{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T01:25:30Z","timestamp":1792027530402,"version":"4.4.0"},"reference-count":43,"publisher":"Oxford University Press (OUP)","issue":"5","license":[{"start":{"date-parts":[[2022,3,23]],"date-time":"2022-03-23T00:00:00Z","timestamp":1647993600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"DOI":"10.13039\/100016956","name":"Melinta Therapeutics","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100016956","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"published-print":{"date-parts":[[2022,5,1]]},"abstract":"<jats:title>Abstract<\/jats:title>\n               <jats:sec>\n                  <jats:title>Background<\/jats:title>\n                  <jats:p>There is a need for improved antibiotic formulations for the treatment of acute bacterial skin and soft structure infection (ABSSSI), especially with the rise of antimicrobial resistance among Gram-positive bacteria. A new formulation of oritavancin was developed to reduce intravenous infusion volume (from 1000\u00a0mL to 250\u00a0mL), shorten infusion time (from 3 hours to 1 hour), and provide pharmacies with flexibility in oritavancin preparation (from 5% dextrose in sterile water to either normal saline or 5% dextrose in sterile water) compared with the current formulation.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Methods<\/jats:title>\n                  <jats:p>A total of 102 adult patients with a diagnosis of ABSSSI suspected or confirmed to be caused by a Gram-positive pathogen were randomized 1:1 to receive either the new formulation of oritavancin or the current formulation. After a single 1200-mg intravenous infusion of oritavancin, the relative area-under-the-curve exposure of the new formulation and current formulation groups were compared. Safety and tolerability of the new formulation were assessed for treatment-emergent adverse events, serious adverse events, and changes to laboratory parameters.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Results<\/jats:title>\n                  <jats:p>The area under the curve for 0 hour to 72 hours postdose was very similar in the new formulation group compared with the current formulation group. No differences in treatment-emergent adverse events were observed between the current and new formulation groups, and all treatment-emergent adverse events were consistent with the known safety profile of the current formulation.<\/jats:p>\n               <\/jats:sec>\n               <jats:sec>\n                  <jats:title>Conclusions<\/jats:title>\n                  <jats:p>The new formulation of oritavancin with reduced volume and duration of intravenous infusion demonstrates a safety profile and pharmacokinetics similar to that of the original formulation.<\/jats:p>\n               <\/jats:sec>","DOI":"10.1093\/ofid\/ofac090","type":"journal-article","created":{"date-parts":[[2022,3,25]],"date-time":"2022-03-25T16:23:03Z","timestamp":1648225383000},"source":"Crossref","is-referenced-by-count":21,"title":["Kimyrsa, An Oritavancin-Containing Product: Clinical Study and Review of Properties"],"prefix":"10.1093","volume":"9","author":[{"given":"Randall K","family":"Hoover","sequence":"first","affiliation":[{"name":"Melinta Therapeutics, Dix Hills, New York, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-1746-7462","authenticated-orcid":false,"given":"Martin","family":"Krsak","sequence":"additional","affiliation":[{"name":"University of Colorado School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kyle C","family":"Molina","sequence":"additional","affiliation":[{"name":"University of Colorado School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, Colorado, USA"},{"name":"University of Colorado Hospital, University of Colorado Skaggs School of Pharmacy and Pharmaceutical Sciences, Aurora, Colorado, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kairav","family":"Shah","sequence":"additional","affiliation":[{"name":"Metro Infectious Disease Consultants, Stockbridge, Georgia, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4469-4345","authenticated-orcid":false,"given":"Mark","family":"Redell","sequence":"additional","affiliation":[{"name":"Medical Affairs, Melinta Therapeutics, Morristown, New Jersey, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"286","published-online":{"date-parts":[[2022,3,23]]},"reference":[{"key":"2022040516521956300_CIT0001","doi-asserted-by":"crossref","first-page":"227","DOI":"10.1186\/1471-2334-12-227","article-title":"Prospective, multicenter, observational study of complicated skin and soft tissue infections in hospitalized patients: clinical characteristics, medical treatment, and outcomes.","volume":"12","author":"Lipsky","year":"2012","journal-title":"BMC Infect Dis"},{"key":"2022040516521956300_CIT0002","doi-asserted-by":"crossref","first-page":"E377","DOI":"10.1111\/1469-0691.12235","article-title":"Europe 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