A randomized Phase 2 trial of telavancin versus standard therapy in patients with uncomplicated Staphylococcus aureus bacteremia: the ASSURE study
1 Department of Medicine, Division of Infectious Diseases, Centro de Educación Médica e Investigaciones Clinicas (CEMIC) “Norberto Quirno”, Av. Las Heras 2981, Office #3, Capital Federal (C1425ASG), Buenos Aires, Argentina
2 Wellstar Infectious Disease, Marietta GA, USA
3 eStudy Site, San Diego CA, USA
4 Mercury Street Medical Group, Butte MT, USA
5 Department of Medicine, National University Health System, Singapore, Singapore
6 Infectious Diseases Service, Hospital Clinic–Institut d’investigacions Biomèdiques August Pi i Sunyer, University of Barcelona, Barcelona, Spain
7 Duke Clinical Research Institute, Durham NC, USA
8 Department of Medicine, Division of Infectious Diseases, Duke University Medical Center, Durham NC, USA
9 Theravance, Inc, South San Francisco CA, USA
BMC Infectious Diseases 2014, 14:289 doi:10.1186/1471-2334-14-289Published: 23 May 2014
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.
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.
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%).
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).