Please use this identifier to cite or link to this item: http://hdl.handle.net/2445/102008
Title: A randomized Phase 2 trial of telavancin versus standard therapy in patients with uncomplicated Staphylococcus aureus bacteremia: the ASSURE study.
Author: Stryjewski, Martin E.
Lentnek, Arnold
O'Riordan, William
Pullman, John
Tambyah, Paul Anantharajah
Miró Meda, José M.
Fowler, Vance G.
Barriere, Steven L.
Kitt, Michael M.
Corey, G.Ralph
Keywords: Staphylococcus aureus
Antibiòtics
Contaminació microbiana
Estudi de casos
Infeccions nosocomials
Staphylococcus aureus
Antibiotics
Microbial contamination
Case studies
Nosocomial infections
Issue Date: 23-May-2014
Publisher: BioMed Central
Abstract: Abstract Background Staphylococcus aureus bacteremia is a common infection associated with significant morbidity and mortality. Telavancin is a bactericidal lipoglycopeptide active against Gram-positive pathogens, including methicillin-resistant S. aureus (MRSA). We conducted a randomized, double-blind, Phase 2 trial in patients with uncomplicated S. aureus bacteremia. Methods Patients were randomized to either telavancin or standard therapy (vancomycin or anti-staphylococcal penicillin) for 14 days. Continuation criteria were set to avoid complicated S. aureus bacteremia. The primary end point was clinical cure at 84 days. Results In total, 60 patients were randomized and 58 received ≥1 study medication dose (all-treated), 31 patients fulfilled inclusion/exclusion and continuation criteria (all-treated target [ATT]) (telavancin 15, standard therapy 16), and 17 patients were clinically evaluable (CE) (telavancin 8, standard therapy 9). Mean age (ATT) was 60 years. Intravenous catheters were the most common source of S. aureus bacteremia and ~50% of patients had MRSA. A similar proportion of CE patients were cured in the telavancin (88%) and standard therapy (89%) groups. All patients with MRSA bacteremia were cured and one patient with MSSA bacteremia failed study treatment in each group. Although adverse events (AEs) were more common in the telavancin ATT group (90% vs. 72%), AEs leading to drug discontinuation were similar (7%) in both treatment arms. Potentially clinically significant increases in serum creatinine (≥1.5 mg/dl and at least 50% greater than baseline) were more common in the telavancin group (20% vs. 7%). Conclusions This study suggests that telavancin may have utility for treatment of uncomplicated S. aureus bacteremia; additional studies are warranted. (Telavancin for Treatment of Uncomplicated Staphylococcus Aureus Bacteremia (ASSURE); NCT00062647).
Note: Reproducció del document publicat a: http://dx.doi.org/10.1186/1471-2334-14-289
It is part of: Bmc Infectious Diseases, 2014, vol. 14, p. 289
Related resource: http://dx.doi.org/10.1186/1471-2334-14-289
URI: http://hdl.handle.net/2445/102008
ISSN: 1471-2334
Appears in Collections:Articles publicats en revistes (Medicina)

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