Telavancin versus standard therapy for treatment of complicated skin and skin structure infections caused by gram-positive bacteria: FAST 2 study
Date
2006
Authors
Stryjewski M.E.
Chu V.H.
O'Riordan W.D.
Warren B.L.
Dunbar L.M.
Young D.M.
Vallee M.
Fowler Jr. V.G.
Morganroth J.
Barriere S.L.
Journal Title
Journal ISSN
Volume Title
Publisher
Abstract
Telavancin is a bactericidal lipoglycopeptide with a multifunctional mechanism of action. We conducted a randomized, double blind, active-control phase II trial. Patients S18 years of age with complicated skin and skin structure infections caused by suspected or confirmed gram-positive organisms were randomized to receive either telavancin at 10 mg/kg intravenously every 24 h (q24h) or standard therapy (antistaphylococcal penicillin at 2 g q6h or vancomycin at 1g q12h). A total of 195 patients were randomized and received at least one dose of study medication. Clinical success rates were similar in all analysis populations at test of cure. In microbiologically evaluable patients with Staphylococcus aureus at baseline (n = 91), 96% of the telavancin group and 90% of the standard-therapy group were cured. Among patients with methicillin-resistant S. aureus (MRSA) at baseline (n = 45), clinical cure rates were also 96% for telavancin and 90% for standard therapy. Microbiologic eradication in patients with S. aureus infection was better with telavancin compared to standard therapy (92% versus 78%, P = 0.07) and significantly better in patients with MRSA (92% versus 68%; P = 0.04). Therapy was discontinued for an adverse event (AE) in 6% and 3% of the patients receiving telavancin and standard therapy, respectively. Except for two cases of rash in the telavancin group, these AEs were similar in type and severity in the two groups. The overall incidences and severities of AEs and laboratory abnormalities were similar between the two groups. These data support the ongoing studies assessing the efficacy and safety of telavancin in the treatment of serious gram-positive infections, particularly involving MRSA. Copyright © 2006, American Society for Microbiology. All Rights Reserved.
Description
Keywords
aztreonam, beta lactam antibiotic, cloxacillin, metronidazole, nafcillin, oxacillin, penicillin derivative, quinoline derived antiinfective agent, telavancin, vancomycin, adult, anemia, antibiotic resistance, article, atelectasis, burn infection, cellulitis, chill, clinical trial, constipation, controlled clinical trial, controlled study, diarrhea, disseminated intravascular clotting, double blind procedure, drug blood level, drug efficacy, drug mechanism, drug safety, eosinophilia, eradication therapy, female, gastrointestinal hemorrhage, Gram positive bacterium, headache, heart atrium fibrillation, human, hypokalemia, hypomagnesemia, hypotension, insomnia, kidney failure, leukopenia, liver dysfunction, liver failure, lobar pneumonia, major clinical study, male, methicillin resistant Staphylococcus aureus, microalbuminuria, multicenter study, multiple organ failure, myositis, nausea, phase 2 clinical trial, priority journal, pruritus, QT prolongation, randomized controlled trial, rash, respiratory failure, skin abscess, skin infection, skin ulcer, Staphylococcus aureus, Staphylococcus infection, suicidal ideation, taste disorder, thrombocytopenia, treatment outcome, vomiting, wound infection, Adult, Aminoglycosides, Anti-Bacterial Agents, Double-Blind Method, Female, Gram-Positive Bacteria, Gram-Positive Bacterial Infections, Humans, Male, Penicillins, Skin Diseases, Bacterial, Treatment Outcome, Vancomycin
Citation
Antimicrobial Agents and Chemotherapy
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