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

Qvist N.
Warren B.
Leister-Tebbe H.
Zito E.T.
Pedersen R.
McGovern P.C.
Babinchak T.
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Background: 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.
ceftriaxone, metronidazole, tigecycline, abdominal infection, abscess, adult, anastomosis leakage, antibiotic therapy, APACHE, article, Bacteroides fragilis, Bacteroides infection, Clostridium, Clostridium infection, controlled study, diarrhea, drug efficacy, drug safety, drug withdrawal, Enterobacter, Enterobacteriaceae infection, enterococcal infection, Enterococcus, eradication therapy, Escherichia coli, Escherichia coli infection, female, healing impairment, human, ischemic colitis, Klebsiella, Klebsiella infection, major clinical study, male, minimum inhibitory concentration, multicenter study, nausea, open study, outcome assessment, Peptostreptococcus, Peptostreptococcus infection, phase 3 clinical trial, phase 4 clinical trial, pneumonia, priority journal, Pseudomonas aeruginosa, Pseudomonas infection, randomized controlled trial, sepsis, septic shock, Staphylococcus aureus, Staphylococcus infection, Streptococcus anginosus, Streptococcus infection, surgical infection, treatment response, vomiting
Surgical Infections