{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,4,29]],"date-time":"2026-04-29T21:22:23Z","timestamp":1777497743046,"version":"3.51.4"},"reference-count":15,"publisher":"American Society for Microbiology","issue":"4","license":[{"start":{"date-parts":[[2014,4,1]],"date-time":"2014-04-01T00:00:00Z","timestamp":1396310400000},"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":[[2014,4]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n          <jats:p>\n            U.S. Food and Drug Administration draft guidance for future antibiotic clinical trials of bacterial nosocomial pneumonia recommends the use of diagnostic criteria according to American Thoracic Society\/Infectious Diseases Society of America (ATS\/IDSA) guidelines and the use of a primary endpoint of 28-day all-cause mortality. The effect of applying these guidelines on outcomes of phase III nosocomial pneumonia studies of telavancin was evaluated in a\n            <jats:italic>post hoc<\/jats:italic>\n            analysis. ATS\/IDSA criteria were applied in a blind fashion to the original all-treated (AT) group. Clinical cure rates at final follow-up were determined in the refined AT and clinically evaluable (CE) groups (ATS\/IDSA-AT and ATS\/IDSA-CE, respectively). The exploratory endpoint of 28-day survival was evaluated for the ATS\/IDSA-AT group. Noninferiority of telavancin versus vancomycin was demonstrated, with similar cure rates in the ATS\/IDSA-AT (59% versus 59%) and ATS\/IDSA-CE (83% versus 80%) groups. Cure rates favored telavancin in ATS\/IDSA-CE patients where\n            <jats:named-content xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" content-type=\"genus-species\" xlink:type=\"simple\">Staphylococcus aureus<\/jats:named-content>\n            was the sole pathogen (86% versus 75%). Overall, 28-day survival rates were similar in the telavancin (76%) and vancomycin (77%) groups but lower in telavancin-treated patients with preexisting moderate-to-severe renal impairment (creatinine clearance [CL\n            <jats:sub>CR<\/jats:sub>\n            ] of &lt;50 ml\/min). Telavancin should be administered to patients with moderate-to-severe renal impairment only if treatment benefit outweighs the risk or if no suitable alternatives are available.\n          <\/jats:p>","DOI":"10.1128\/aac.02330-13","type":"journal-article","created":{"date-parts":[[2014,1,14]],"date-time":"2014-01-14T05:33:01Z","timestamp":1389677581000},"page":"2030-2037","update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":47,"title":["Telavancin for Hospital-Acquired Pneumonia: Clinical Response and 28-Day Survival"],"prefix":"10.1128","volume":"58","author":[{"given":"G. Ralph","family":"Corey","sequence":"first","affiliation":[{"name":"Department of Medicine, Duke Clinical Research Institute, Durham, North Carolina, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marin H.","family":"Kollef","sequence":"additional","affiliation":[{"name":"Pulmonary and Critical Care Division, Washington University School of Medicine, St. Louis, Missouri, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Andrew F.","family":"Shorr","sequence":"additional","affiliation":[{"name":"Pulmonary and Critical Care Medicine, Washington Hospital Center, Washington, DC, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Ethan","family":"Rubinstein","sequence":"additional","affiliation":[{"name":"University of Manitoba, Winnipeg, Manitoba, Canada"}],"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, Buenos Aires, Argentina"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alan","family":"Hopkins","sequence":"additional","affiliation":[{"name":"Theravance, Inc., South San Francisco, California, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Steven L.","family":"Barriere","sequence":"additional","affiliation":[{"name":"Theravance, Inc., South San Francisco, California, USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"235","reference":[{"key":"e_1_3_2_2_2","doi-asserted-by":"publisher","DOI":"10.1164\/rccm.200405-644ST"},{"key":"e_1_3_2_3_2","doi-asserted-by":"publisher","DOI":"10.1378\/chest.127.1.213"},{"key":"e_1_3_2_4_2","doi-asserted-by":"publisher","DOI":"10.1164\/ajrccm.165.7.2105078"},{"key":"e_1_3_2_5_2","doi-asserted-by":"publisher","DOI":"10.1097\/CCM.0b013e318168fbe0"},{"key":"e_1_3_2_6_2","doi-asserted-by":"publisher","DOI":"10.1097\/00003246-200209000-00016"},{"key":"e_1_3_2_7_2","doi-asserted-by":"publisher","DOI":"10.1086\/533594"},{"key":"e_1_3_2_8_2","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2010.757"},{"key":"e_1_3_2_9_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.01710-08"},{"key":"e_1_3_2_10_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.01398-07"},{"key":"e_1_3_2_11_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.47.11.3602-3604.2003"},{"key":"e_1_3_2_12_2","doi-asserted-by":"publisher","DOI":"10.1093\/cid\/ciq031"},{"key":"e_1_3_2_13_2","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. Hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia: developing drugs for treatment. Draft guidance. http:\/\/www.fda.gov\/downloads\/Drugs\/GuidanceComplianceRegulatoryInformation\/Guidances\/UCM234907.pdf. Accessed 10 July 2013."},{"key":"e_1_3_2_14_2","doi-asserted-by":"publisher","DOI":"10.1086\/318486"},{"key":"e_1_3_2_15_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1469-0691.2006.01344.x"},{"key":"e_1_3_2_16_2","doi-asserted-by":"publisher","DOI":"10.1128\/CMR.00042-09"}],"updated-by":[{"DOI":"10.1128\/aac.02899-14","type":"correction","label":"Correction","source":"publisher","updated":{"date-parts":[[2014,5,14]],"date-time":"2014-05-14T00:00:00Z","timestamp":1400025600000}}],"container-title":["Antimicrobial Agents and Chemotherapy"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/AAC.02330-13","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/AAC.02330-13","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,2,21]],"date-time":"2022-02-21T22:42:50Z","timestamp":1645483370000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.asm.org\/doi\/10.1128\/AAC.02330-13"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2014,4]]},"references-count":15,"journal-issue":{"issue":"4","published-print":{"date-parts":[[2014,4]]}},"alternative-id":["10.1128\/AAC.02330-13"],"URL":"https:\/\/doi.org\/10.1128\/aac.02330-13","relation":{},"ISSN":["0066-4804","1098-6596"],"issn-type":[{"value":"0066-4804","type":"print"},{"value":"1098-6596","type":"electronic"}],"subject":[],"published":{"date-parts":[[2014,4]]},"assertion":[{"value":"2013-11-06","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2014-01-08","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2014-03-18","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}