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Publication Details
AFRICAN RESEARCH NEXUS
SHINING A SPOTLIGHT ON AFRICAN RESEARCH
medicine
Efficacy of tigecycline versus ceftriaxone plus metronidazole for the treatment of complicated intra-abdominal infections: Results from a randomized, controlled trial
Surgical Infections, Volume 13, No. 2, Year 2012
Notification
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Description
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.
Authors & Co-Authors
Qvist, Niels
Denmark, Odense
Odense Universitetshospital
Warren, Brian Leigh
South Africa, Tygerberg
Tygerberg Hospital
Leister-Tebbe, Heidi K.
United States, New York
Pfizer Inc.
Zito, Edward T.
United States, New York
Pfizer Inc.
Pedersen, Ronald D.
United States, New York
Pfizer Inc.
McGovern, Paul C.
United States, New York
Pfizer Inc.
Babinchak, Timothy J.
United States, New York
Pfizer Inc.
Statistics
Citations: 33
Authors: 7
Affiliations: 3
Identifiers
Doi:
10.1089/sur.2011.048
ISSN:
10962964
e-ISSN:
15578674
Research Areas
Health System And Policy
Study Design
Cross Sectional Study