{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,11,11]],"date-time":"2025-11-11T13:10:47Z","timestamp":1762866647219},"reference-count":11,"publisher":"American Society for Microbiology","issue":"10","license":[{"start":{"date-parts":[[2015,10,1]],"date-time":"2015-10-01T00:00:00Z","timestamp":1443657600000},"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":[[2015,10]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n          <jats:p>\n            Two phase 3 ATLAS trials demonstrated noninferiority of telavancin compared with vancomycin for complicated skin and skin structure infections. Data from these trials were retrospectively evaluated according to 2013 U.S. Food and Drug Administration (FDA) guidance on acute bacterial skin and skin structure infections. This\n            <jats:italic>post hoc<\/jats:italic>\n            analysis included patients with lesion sizes of \u226575 cm\n            <jats:sup>2<\/jats:sup>\n            and excluded patients with ulcers or burns (updated all-treated population;\n            <jats:italic>n<\/jats:italic>\n            = 1,127). Updated day 3 (early) clinical response was defined as a \u226520% reduction in lesion size from baseline and no rescue antibiotic. Updated test-of-cure (TOC) clinical response was defined as a \u226590% reduction in lesion size, no increase in lesion size since day 3, and no requirement for additional antibiotics or significant surgical procedures. Day 3 (early) clinical responses were achieved in 62.6% and 61.0% of patients receiving telavancin and vancomycin, respectively (difference, 1.7%, with a 95% confidence interval [CI] of \u22124.0% to 7.4%). Updated TOC visit cure rates were similar for telavancin (68.0%) and vancomycin (63.3%), with a difference of 4.8% (95% CI, \u22120.7% to 10.3%). Adopting current FDA guidance, this analysis corroborates previous noninferiority findings of the ATLAS trials of telavancin compared with vancomycin.\n          <\/jats:p>","DOI":"10.1128\/aac.00471-15","type":"journal-article","created":{"date-parts":[[2015,7,28]],"date-time":"2015-07-28T01:31:15Z","timestamp":1438047075000},"page":"6170-6174","update-policy":"http:\/\/dx.doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":7,"title":["Telavancin for Acute Bacterial Skin and Skin Structure Infections, a\n            <i>Post Hoc<\/i>\n            Analysis of the Phase 3 ATLAS Trials in Light of the 2013 FDA Guidance"],"prefix":"10.1128","volume":"59","author":[{"given":"Richard","family":"Pushkin","sequence":"first","affiliation":[{"name":"Theravance Biopharma US, Inc., South San Francisco, California, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Steven L.","family":"Barriere","sequence":"additional","affiliation":[{"name":"Theravance Biopharma US, Inc., South San Francisco, California, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Whedy","family":"Wang","sequence":"additional","affiliation":[{"name":"Theravance Biopharma US, Inc., South San Francisco, California, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"G. Ralph","family":"Corey","sequence":"additional","affiliation":[{"name":"Duke Clinical Research Institute and Division of Infectious Diseases, Duke University Medical Center, Durham, North Carolina, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Martin E.","family":"Stryjewski","sequence":"additional","affiliation":[{"name":"Department of Medicine, Section of Infectious Diseases, Centro de Educaci\u00f3n M\u00e9dica e Investigaciones Cl\u00ednicas Norberto Quirno (CEMIC), Buenos Aires, Argentina"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"235","reference":[{"key":"e_1_3_2_2_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.49.3.1127-1134.2005"},{"key":"e_1_3_2_3_2","doi-asserted-by":"publisher","DOI":"10.1517\/14656566.9.12.2197"},{"key":"e_1_3_2_4_2","volume-title":"Abstr 54th Intersci Conf Antimicrob Agents Chemother","author":"Smith JR","unstructured":"Smith JR, Barber KE, Raut A, Rybak MJ. Minimum inhibitory concentrations (MIC) of telavancin (TLV) against methicillin resistant Staphylococcus aureus (MRSA) with reduced susceptibility to daptomycin (DAP), vancomycin (VAN), or linezolid (LZD), abstr A-1311. Abstr 54th Intersci Conf Antimicrob Agents Chemother."},{"key":"e_1_3_2_5_2","doi-asserted-by":"publisher","DOI":"10.1097\/01.inf.0000109288.06912.21"},{"key":"e_1_3_2_6_2","doi-asserted-by":"publisher","DOI":"10.1086\/587896"},{"key":"e_1_3_2_7_2","volume-title":"Summary basis of decision (SBD) PrVIBATIV","author":"Health Canada","year":"2010","unstructured":"Health Canada. 10 February 2010. Summary basis of decision (SBD) PrVIBATIV. Health Canada, Ottawa, Ontario, Canada. http:\/\/www.hc-sc.gc.ca\/dhp-mps\/alt_formats\/pdf\/prodpharma\/sbdsmd\/phase1-decision\/drug-med\/sbd_smd_2010_vibativ_107792-eng.pdf. Accessed 28 January 2015."},{"key":"e_1_3_2_8_2","volume-title":"VIBATIV (telavancin) prescribing information","author":"Theravance Biopharma Antibiotics, Inc","year":"2014","unstructured":"Theravance Biopharma Antibiotics, Inc. December 2014. VIBATIV (telavancin) prescribing information. Theravance Biopharma US, Inc., South San Francisco, CA. http:\/\/www.vibativ.com\/docs\/VIBATIV_PI_Final.pdf. Accessed 28 January 2015."},{"key":"e_1_3_2_9_2","volume-title":"Uncomplicated and complicated skin and skin structure infections\u2014developing antimicrobial drugs for treatment. Draft guidance","author":"US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research","year":"1998","unstructured":"US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research. July 1998, posting date. Guidance for industry. Uncomplicated and complicated skin and skin structure infections\u2014developing antimicrobial drugs for treatment. Draft guidance. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD. http:\/\/www.fda.gov\/ohrms\/dockets\/98fr\/2566dft.pdf. Accessed 28 January 2015."},{"key":"e_1_3_2_10_2","volume-title":"Acute bacterial skin and skin structure infections: developing drugs for treatment. Draft guidance","author":"US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research","year":"2013","unstructured":"US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research. October 2013, posting date. Guidance for industry. Acute bacterial skin and skin structure infections: developing drugs for treatment. Draft guidance. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD. http:\/\/www.fda.gov\/downloads\/Drugs\/.\/Guidances\/ucm071185.pdf. Accessed 28 January 2015."},{"key":"e_1_3_2_11_2","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/cis566"},{"key":"e_1_3_2_12_2","volume-title":"Guidance for industry. Antibacterial drug products: use of noninferiority trials to support approval. Draft guidance","author":"US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research","year":"2010","unstructured":"US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research. November 2010, posting date. Guidance for industry. Antibacterial drug products: use of noninferiority trials to support approval. Draft guidance. US Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research, Silver Spring, MD. http:\/\/www.fda.gov\/downloads\/Drugs\/GuidanceComplianceRegulatoryInformation\/Guidances\/ucm070951.pdf. Accessed 28 January 2015."}],"container-title":["Antimicrobial Agents and Chemotherapy"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/AAC.00471-15","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/AAC.00471-15","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,2,21]],"date-time":"2022-02-21T22:49:02Z","timestamp":1645483742000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.asm.org\/doi\/10.1128\/AAC.00471-15"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2015,10]]},"references-count":11,"journal-issue":{"issue":"10","published-print":{"date-parts":[[2015,10]]}},"alternative-id":["10.1128\/AAC.00471-15"],"URL":"https:\/\/doi.org\/10.1128\/aac.00471-15","relation":{},"ISSN":["0066-4804","1098-6596"],"issn-type":[{"value":"0066-4804","type":"print"},{"value":"1098-6596","type":"electronic"}],"subject":[],"published":{"date-parts":[[2015,10]]},"assertion":[{"value":"2015-03-02","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2015-07-10","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2015-09-18","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}