{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,3]],"date-time":"2026-10-03T20:52:26Z","timestamp":1791060746037,"version":"4.1.0"},"reference-count":23,"publisher":"American Society for Microbiology","issue":"11","license":[{"start":{"date-parts":[[2011,11,1]],"date-time":"2011-11-01T00:00:00Z","timestamp":1320105600000},"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":[[2011,11]]},"abstract":"<jats:title>ABSTRACT<\/jats:title>\n          <jats:p>\n            A 10-day course of oral fidaxomicin (200 mg twice a day [b.i.d.]), a potent new macrocyclic drug, was compared to vancomycin (125 mg four times a day [q.i.d.]) in 1,164 adults (1,105 in the modified intent-to-treat [mITT] population) with\n            <jats:named-content xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" content-type=\"genus-species\" xlink:type=\"simple\">Clostridium difficile<\/jats:named-content>\n            infection in two phase III randomized, double-blind trials at sites in North America and 7 European countries. Of 1,105 mITT patients, 792 (71.7%), including 719\/999 (72.0%) in the per-protocol (PP) population, provided a\n            <jats:named-content xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" content-type=\"genus-species\" xlink:type=\"simple\">C. difficile<\/jats:named-content>\n            strain at baseline, of whom 356 received fidaxomicin with 330 cures (92.7%) and 363 received vancomycin with 329 cures (90.6%). The susceptibilities (MIC\n            <jats:sub>90<\/jats:sub>\n            ) of baseline isolates did not predict clinical cure, failure, or recurrence for fidaxomicin (MIC\n            <jats:sub>90<\/jats:sub>\n            , 0.25 \u03bcg\/ml for both; range, \u22640.007 to 1 \u03bcg\/ml), but there was a one-dilution difference in the MIC\n            <jats:sub>90<\/jats:sub>\n            (but not the MIC\n            <jats:sub>50<\/jats:sub>\n            ) for vancomycin (MIC\n            <jats:sub>90<\/jats:sub>\n            , 2 \u03bcg\/ml [range, 0.25 to 8 \u03bcg\/ml] for cure and 4.0 \u03bcg\/ml [range, 0.5 to 4 \u03bcg\/ml] for failures). A total of 65 (7.9%) \u201crifaximin-resistant\u201d (MIC &gt; 256 \u03bcg\/ml) strains were isolated in both treatment groups on enrollment, which increased to 25% for failures at the end of therapy. No resistance to either fidaxomicin or vancomycin developed during treatment in either of the phase III studies, although a single strain isolated from a cured patient had an elevated fidaxomicin MIC of 16 \u03bcg\/ml at the time of recurrence. All isolates were susceptible to \u22644 \u03bcg\/ml of metronidazole. When analyzed by restriction endonuclease analysis (REA) type, 247\/719 (34.4%) isolates were BI group isolates, and the MICs were generally higher for all four drugs tested (MIC\n            <jats:sub>90<\/jats:sub>\n            s: fidaxomicin, 0.5; vancomycin, 2.0; metronidazole, 2.0; and rifaximin, &gt;256 \u03bcg\/ml) than for the other REA types. There was no correlation between the MIC of a baseline clinical isolate and clinical outcome. MIC\n            <jats:sub>90<\/jats:sub>\n            s were generally low for fidaxomicin and vancomycin, but BI isolates had higher MICs than other REA group isolates.\n          <\/jats:p>","DOI":"10.1128\/aac.00625-11","type":"journal-article","created":{"date-parts":[[2011,8,16]],"date-time":"2011-08-16T05:37:29Z","timestamp":1313473049000},"page":"5194-5199","update-policy":"https:\/\/doi.org\/10.1128\/asmj-crossmark-policy-page","source":"Crossref","is-referenced-by-count":97,"title":["Comparative Susceptibilities to Fidaxomicin (OPT-80) of Isolates Collected at Baseline, Recurrence, and Failure from Patients in Two Phase III Trials of Fidaxomicin against Clostridium difficile Infection"],"prefix":"10.1128","volume":"55","author":[{"given":"Ellie J. C.","family":"Goldstein","sequence":"first","affiliation":[{"name":"R. M. Alden Research Laboratory, Culver City, California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Diane M.","family":"Citron","sequence":"additional","affiliation":[{"name":"R. M. Alden Research Laboratory, Culver City, California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pamela","family":"Sears","sequence":"additional","affiliation":[{"name":"Optimer Pharmaceuticals Inc., San Diego, California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Farah","family":"Babakhani","sequence":"additional","affiliation":[{"name":"Optimer Pharmaceuticals Inc., San Diego, California"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Susan P.","family":"Sambol","sequence":"additional","affiliation":[{"name":"Hines VA Hospital, Hines, Illinois"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dale N.","family":"Gerding","sequence":"additional","affiliation":[{"name":"Hines VA Hospital, Hines, Illinois"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"235","reference":[{"key":"e_1_3_2_2_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.48.6.2280-2282.2004"},{"key":"e_1_3_2_3_2","doi-asserted-by":"publisher","DOI":"10.1086\/588293"},{"key":"e_1_3_2_4_2","doi-asserted-by":"publisher","DOI":"10.1086\/597507"},{"key":"e_1_3_2_5_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.anaerobe.2009.09.005"},{"key":"e_1_3_2_6_2","doi-asserted-by":"publisher","DOI":"10.1128\/jcm.31.7.1870-1875.1993"},{"key":"e_1_3_2_7_2","unstructured":"Clinical and Laboratory Standards Institute. 2007. Methods for antimicrobial susceptibility testing of anaerobic bacteria 7th ed. CLSI document M11-A7. CLSI Wayne PA."},{"key":"e_1_3_2_8_2","unstructured":"Clinical and Laboratory Standards Institute. 2011. Performance standards for antimicrobial susceptibility testing; 21st informational supplement. CLSI document M100-S21. CLSI Wayne PA."},{"key":"e_1_3_2_9_2","doi-asserted-by":"publisher","DOI":"10.1086\/651706"},{"key":"e_1_3_2_10_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.48.11.4430-4434.2004"},{"key":"e_1_3_2_11_2","volume-title":"Proc. 20th Eur. Congr. Microbiol. Infect. Dis.","author":"Crook D.","year":"2010","unstructured":"CrookD.. 2010. Randomized clinical trial of Clostridium difficile infection confirms equivalent cure rate and lower recurrence rate of fidaxomicin versus vancomycin, abstr. LB 2041. Proc. 20th Eur. Congr. Microbiol. Infect. Dis., Vienna, Austria."},{"key":"e_1_3_2_12_2","doi-asserted-by":"publisher","DOI":"10.1086\/596315"},{"key":"e_1_3_2_13_2","doi-asserted-by":"publisher","DOI":"10.1128\/CMR.00082-09"},{"key":"e_1_3_2_14_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.48.12.4898-4902.2004"},{"key":"e_1_3_2_15_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.01623-06"},{"key":"e_1_3_2_16_2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ijantimicag.2009.09.012"},{"key":"e_1_3_2_17_2","doi-asserted-by":"publisher","DOI":"10.1086\/511870"},{"key":"e_1_3_2_18_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.00476-08"},{"key":"e_1_3_2_19_2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa0910812"},{"key":"e_1_3_2_20_2","doi-asserted-by":"publisher","DOI":"10.1002\/14651858.CD004610.pub3"},{"key":"e_1_3_2_21_2","doi-asserted-by":"publisher","DOI":"10.1128\/JCM.00524-08"},{"key":"e_1_3_2_22_2","doi-asserted-by":"publisher","DOI":"10.7164\/antibiotics.28.543"},{"key":"e_1_3_2_23_2","doi-asserted-by":"publisher","DOI":"10.1128\/AAC.35.6.1108"},{"key":"e_1_3_2_24_2","doi-asserted-by":"publisher","DOI":"10.1086\/519265"}],"container-title":["Antimicrobial Agents and Chemotherapy"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/AAC.00625-11","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/journals.asm.org\/doi\/pdf\/10.1128\/AAC.00625-11","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2022,2,21]],"date-time":"2022-02-21T23:18:41Z","timestamp":1645485521000},"score":1,"resource":{"primary":{"URL":"https:\/\/journals.asm.org\/doi\/10.1128\/AAC.00625-11"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2011,11]]},"references-count":23,"journal-issue":{"issue":"11","published-print":{"date-parts":[[2011,11]]}},"alternative-id":["10.1128\/AAC.00625-11"],"URL":"https:\/\/doi.org\/10.1128\/aac.00625-11","relation":{},"ISSN":["0066-4804","1098-6596"],"issn-type":[{"value":"0066-4804","type":"print"},{"value":"1098-6596","type":"electronic"}],"subject":[],"published":{"date-parts":[[2011,11]]},"assertion":[{"value":"2011-05-04","order":0,"name":"received","label":"Received","group":{"name":"publication_history","label":"Publication History"}},{"value":"2011-08-03","order":1,"name":"accepted","label":"Accepted","group":{"name":"publication_history","label":"Publication History"}},{"value":"2011-10-14","order":2,"name":"published","label":"Published","group":{"name":"publication_history","label":"Publication History"}}]}}