Efficacy of tigecycline versus ceftriaxone plus metronidazole for the treatment of complicated intra-abdominal infections: Results from a randomized, controlled trial

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dc.contributor.authorQvist N.
dc.contributor.authorWarren B.
dc.contributor.authorLeister-Tebbe H.
dc.contributor.authorZito E.T.
dc.contributor.authorPedersen R.
dc.contributor.authorMcGovern P.C.
dc.contributor.authorBabinchak T.
dc.date.accessioned2012-05-17T08:14:42Z
dc.date.available2012-05-17T08:14:42Z
dc.date.issued2012
dc.description.abstractBackground: This randomized, open-label, multi-center trial compared tigecycline (TGC), a broad-spectrum glycylcycline, with ceftriaxone- metronidazole (CTX/MET) for the treatment of complicated intra-abdominal infections (cIAI). Methods: Eligible subjects were randomized to receive TGC 100 mg followed by 50 mg q 12 h or CTX 2 g qd plus MET 1-2 g daily for 4-14 days. Subjects were stratified by Acute Physiology and Chronic Health Evaluation (APACHE) II score ≤10 or >10 and could not receive oral therapy. The primary endpoint was clinical response in the clinically evaluable (CE) population at the test of cure (TOC) assessment 8-44 days after the last drug dose. Results: Clinical responses in the CE population were 81.8% (162/198) vs. 79.4% (150/189) for TGC and CTX/MET, respectively; a weighted estimate of the difference of 1.6 (95% confidence interval [CI] -6.4, 9.6). In the microbiologically evaluable (ME) population, microbiological eradication rates were 82.4% (98/119) for TGC vs. 79.6% (86/108) for CTX/MET: a difference of 2.7 (95% CI -7.9, 13.3). Common adverse events were nausea (21.6% TGC vs. 21.3% CTX/MET) and vomiting (17.7% TGC vs. 13.2% CTX/MET). Discontinuation rates because of adverse events were 7.8% for TGC and 6.4% for CTX/MET. Conclusions: Tigecycline was effective in the treatment of cIAI and was non-inferior to CTX/MET for the treatment of cIAI in hospitalized adults. © Copyright 2012, Mary Ann Liebert, Inc.
dc.identifier.citationSurgical Infections
dc.identifier.citation13
dc.identifier.citation2
dc.identifier.citation102
dc.identifier.citation109
dc.identifier.issn10962964
dc.identifier.other10.1089/sur.2011.048
dc.identifier.urihttp://hdl.handle.net/10019.1/21004
dc.subjectceftriaxone
dc.subjectmetronidazole
dc.subjecttigecycline
dc.subjectabdominal infection
dc.subjectabscess
dc.subjectadult
dc.subjectanastomosis leakage
dc.subjectantibiotic therapy
dc.subjectAPACHE
dc.subjectarticle
dc.subjectBacteroides fragilis
dc.subjectBacteroides infection
dc.subjectClostridium
dc.subjectClostridium infection
dc.subjectcontrolled study
dc.subjectdiarrhea
dc.subjectdrug efficacy
dc.subjectdrug safety
dc.subjectdrug withdrawal
dc.subjectEnterobacter
dc.subjectEnterobacteriaceae infection
dc.subjectenterococcal infection
dc.subjectEnterococcus
dc.subjecteradication therapy
dc.subjectEscherichia coli
dc.subjectEscherichia coli infection
dc.subjectfemale
dc.subjecthealing impairment
dc.subjecthuman
dc.subjectischemic colitis
dc.subjectKlebsiella
dc.subjectKlebsiella infection
dc.subjectmajor clinical study
dc.subjectmale
dc.subjectminimum inhibitory concentration
dc.subjectmulticenter study
dc.subjectnausea
dc.subjectopen study
dc.subjectoutcome assessment
dc.subjectPeptostreptococcus
dc.subjectPeptostreptococcus infection
dc.subjectphase 3 clinical trial
dc.subjectphase 4 clinical trial
dc.subjectpneumonia
dc.subjectpriority journal
dc.subjectPseudomonas aeruginosa
dc.subjectPseudomonas infection
dc.subjectrandomized controlled trial
dc.subjectsepsis
dc.subjectseptic shock
dc.subjectStaphylococcus aureus
dc.subjectStaphylococcus infection
dc.subjectStreptococcus anginosus
dc.subjectStreptococcus infection
dc.subjectsurgical infection
dc.subjecttreatment response
dc.subjectvomiting
dc.titleEfficacy of tigecycline versus ceftriaxone plus metronidazole for the treatment of complicated intra-abdominal infections: Results from a randomized, controlled trial
dc.typeArticle
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