A randomized Phase 2 trial of telavancin versus standard therapy in patients with uncomplicated Staphylococcus aureus bacteremia: the ASSURE study.
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).
Type
Journal articleSubject
AdultAged
Aged, 80 and over
Aminoglycosides
Anti-Bacterial Agents
Bacteremia
Catheter-Related Infections
Double-Blind Method
Female
Humans
Male
Methicillin-Resistant Staphylococcus aureus
Middle Aged
Penicillins
Staphylococcal Infections
Staphylococcus aureus
Treatment Outcome
Vancomycin
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https://hdl.handle.net/10161/13314Published Version (Please cite this version)
10.1186/1471-2334-14-289Publication Info
Stryjewski, Martin E; Lentnek, Arnold; O'Riordan, William; Pullman, John; Tambyah,
Paul Anantharajah; Miró, Jose M; ... Corey, G Ralph (2014). A randomized Phase 2 trial of telavancin versus standard therapy in patients with
uncomplicated Staphylococcus aureus bacteremia: the ASSURE study. BMC Infect Dis, 14. pp. 289. 10.1186/1471-2334-14-289. Retrieved from https://hdl.handle.net/10161/13314.This is constructed from limited available data and may be imprecise. To cite this
article, please review & use the official citation provided by the journal.
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Show full item recordScholars@Duke
Gordon Ralph Corey
Gary Hock Distinguished Professor Emeritus in Global Health, in the School of Medicine
My research is based at the Duke Clinical Research Institute, a large academic clinical
research organization designed to conduct clinical trials from small local studies
to worldwide trials. The focus of my research is bacterial infections: complicated
skin and skin structure infections; postoperative wound infections; hospital-acquired
and ventilator-associated pneumonia; bacteremia; and endocarditis. Many of these trials
are conducted in concert with the pharmaceutical industry in order to re
Vance Garrison Fowler Jr.
Florence McAlister Distinguished Professor of Medicine
Determinants of Outcome in Patients with Staphylococcus aureus Bacteremia Antibacterial
ResistancePathogenesis of Bacterial Infections Tropical medicine/International Health
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