A randomized Phase 2 trial of telavancin versus standard therapy in patients with uncomplicated Staphylococcus aureus bacteremia: the ASSURE study.

Stryjewski, Martin E

Lentnek, Arnold

O'Riordan, William

Pullman, John

Tambyah, Paul Anantharajah

Miró, Jose M

Fowler, Vance G

Barriere, Steven L

Kitt, Michael M

Corey, G Ralph

England

2017-01-01T20:08:10Z

2014-05-23

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).

http://www.ncbi.nlm.nih.gov/pubmed/24884578

1471-2334-14-289

1471-2334

https://hdl.handle.net/10161/13314

eng

Springer Science and Business Media LLC

BMC Infect Dis

10.1186/1471-2334-14-289

Adult

Aged

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

A randomized Phase 2 trial of telavancin versus standard therapy in patients with uncomplicated Staphylococcus aureus bacteremia: the ASSURE study.

Journal article

Fowler, Vance G|0000-0002-8048-0897

http://www.ncbi.nlm.nih.gov/pubmed/24884578

289

Basic Science Departments

Clinical Science Departments

Duke

Duke Clinical Research Institute

Global Health Institute

Institutes and Centers

Institutes and Provost's Academic Units

Medicine

Medicine, Infectious Diseases

Molecular Genetics and Microbiology

Pathology

School of Medicine

University Institutes and Centers

Published online

14