PMID- 24884578
OWN - NLM
STAT- MEDLINE
DCOM- 20150623
LR  - 20220408
IS  - 1471-2334 (Electronic)
IS  - 1471-2334 (Linking)
VI  - 14
DP  - 2014 May 23
TI  - A randomized Phase 2 trial of telavancin versus standard therapy in patients with 
      uncomplicated Staphylococcus aureus bacteremia: the ASSURE study.
PG  - 289
LID - 10.1186/1471-2334-14-289 [doi]
AB  - 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).
FAU - Stryjewski, Martin E
AU  - Stryjewski ME
AD  - Department of Medicine, Division of Infectious Diseases, Centro de Educacion 
      Medica e Investigaciones Clinicas (CEMIC) "Norberto Quirno", Av, Las Heras 2981, 
      Office #3, Capital Federal (C1425ASG), Buenos Aires, Argentina. 
      stryj001@fibertel.com.ar.
FAU - Lentnek, Arnold
AU  - Lentnek A
FAU - O'Riordan, William
AU  - O'Riordan W
FAU - Pullman, John
AU  - Pullman J
FAU - Tambyah, Paul Anantharajah
AU  - Tambyah PA
FAU - Miro, Jose M
AU  - Miro JM
FAU - Fowler, Vance G Jr
AU  - Fowler VG Jr
FAU - Barriere, Steven L
AU  - Barriere SL
FAU - Kitt, Michael M
AU  - Kitt MM
FAU - Corey, G Ralph
AU  - Corey GR
LA  - eng
SI  - ClinicalTrials.gov/NCT00062647
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20140523
PL  - England
TA  - BMC Infect Dis
JT  - BMC infectious diseases
JID - 100968551
RN  - 0 (Aminoglycosides)
RN  - 0 (Anti-Bacterial Agents)
RN  - 0 (Lipoglycopeptides)
RN  - 0 (Penicillins)
RN  - 6Q205EH1VU (Vancomycin)
RN  - XK134822Z0 (telavancin)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Aged, 80 and over
MH  - Aminoglycosides/adverse effects/*therapeutic use
MH  - Anti-Bacterial Agents/*therapeutic use
MH  - Bacteremia/*drug therapy/microbiology
MH  - Catheter-Related Infections/complications/microbiology
MH  - Double-Blind Method
MH  - Female
MH  - Humans
MH  - Lipoglycopeptides
MH  - Male
MH  - Methicillin-Resistant Staphylococcus aureus/drug effects/pathogenicity
MH  - Middle Aged
MH  - Penicillins/therapeutic use
MH  - Staphylococcal Infections/*drug therapy/microbiology
MH  - Staphylococcus aureus/drug effects/*pathogenicity
MH  - Treatment Outcome
MH  - Vancomycin/therapeutic use
PMC - PMC4048626
EDAT- 2014/06/03 06:00
MHDA- 2015/06/24 06:00
PMCR- 2014/05/23
CRDT- 2014/06/03 06:00
PHST- 2013/11/11 00:00 [received]
PHST- 2014/04/24 00:00 [accepted]
PHST- 2014/06/03 06:00 [entrez]
PHST- 2014/06/03 06:00 [pubmed]
PHST- 2015/06/24 06:00 [medline]
PHST- 2014/05/23 00:00 [pmc-release]
AID - 1471-2334-14-289 [pii]
AID - 10.1186/1471-2334-14-289 [doi]
PST - epublish
SO  - BMC Infect Dis. 2014 May 23;14:289. doi: 10.1186/1471-2334-14-289.