Telavancin versus standard therapy for treatment of complicated skin and soft-tissue infections due to gram-positive bacteria.
BACKGROUND
Telavancin, a novel lipoglycopeptide, exerts concentration-dependent, rapid bactericidal activity on account of its multiple mechanisms of action. Telavancin is highly active against gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-intermediate, and vancomycin-resistant strains.


METHODS
We conducted a randomized, double-blind, controlled, phase-2 clinical trial. Patients > or = 18 years of age with a diagnosis of complicated skin and soft-tissue infection caused by suspected or confirmed gram-positive organisms were randomized to receive either intravenously administered telavancin once daily or standard therapy (antistaphylococcal penicillin 4 times daily or vancomycin twice daily).


RESULTS
For the study, 167 patients were randomized and received at least 1 dose of study medication. Success rates were similar in all analysis populations at the test-of-cure evaluation. Of patients with S. aureus infection at baseline (n = 102), 80% of the telavancin group were cured and 77% of the standard therapy group were cured. For patients with MRSA infection at baseline (n = 48), cure rates were 82% for the telavancin group and 69% for the standard therapy group. Microbiologic eradication in patients with MRSA infection was 84% for the telavancin group versus 74% for the standard therapy group. MIC90 values were lower for telavancin in all tested strains of S. aureus (< or = 0.25 ug/mL) compared with the MIC90 values for vancomycin and oxacillin. Similar proportions of patients discontinued therapy for adverse events in both treatment groups (approximately 5%). Fewer serious adverse events were reported in the telavancin group (4 events) than were for the standard therapy group (9).


CONCLUSIONS
Clinical and microbiological results of this study support the further development of telavancin, especially for treatment of infection due to MRSA.
Stryjewski
Martin E
ME
Division of Infectious Diseases, Duke University Medical Center, Durham, North Carolina, USA.
O'Riordan
William D
WD
Lau
William K
WK
Pien
Francis D
FD
Dunbar
Lala M
LM
Vallee
Marc
M
Fowler
Vance G
VG
Chu
Vivian H
VH
Spencer
Elizabeth
E
Barriere
Steven L
SL
Kitt
Michael M
MM
Cabell
Christopher H
CH
Corey
G Ralph
GR
D000328:Adult; D000617:Aminoglycosides / Q000009:adverse effects / Q000627:therapeutic use*; D000900:Anti-Bacterial Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D016908:Gram-Positive Bacterial Infections / Q000188:drug therapy* / Q000382:microbiology; D006801:Humans; D000077427:Lipoglycopeptides; D008297:Male; D008875:Middle Aged; D010406:Penicillins / Q000009:adverse effects / Q000627:therapeutic use; D017192:Skin Diseases, Bacterial / Q000188:drug therapy* / Q000382:microbiology*; D018461:Soft Tissue Infections / Q000188:drug therapy* / Q000382:microbiology*; D014640:Vancomycin / Q000009:adverse effects / Q000627:therapeutic use
D000617:Aminoglycosides; D000900:Anti-Bacterial Agents; D000077427:Lipoglycopeptides; D010406:Penicillins; D014640:Vancomycin; C487637:telavancin