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

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

Safety, Efficacy and Pharmacokinetics of Anidulafungin in Patients 1 Month to <2 Years of Age with Invasive Candidiasis, including Candidemia

Nineteen patients 1 month to &lt;2 years of age with (n = 16) or at high risk of (n = 3) invasive candidiasis received anidulafungin for 5-35 days (3 mg/kg day 1, 1.5 mg/kg daily thereafter) followed by optional fluconazole (NCT00761267). Most treatment-emergent adverse events were mild/moderate, and no treatment-related deaths occurred. End of intravenous therapy global response success rate was 68.8%. Pharmacokinetics were similar to adult patients