Telavancin Versus Standard Therapy for Treatment of Complicated Skin and Soft-Tissue Infections Due to Gram-Positive Bacteria

• Published in: Clinical infectious diseases 2005-06, Vol.40 (11), p.1601-1607
• Main Authors: Stryjewski, Martin E., O'Riordan, William D., Lau, William K., Pien, Francis D., Dunbar, Lala M., Vallee, Marc, Fowler, Vance G., Chu, Vivian H., Spencer, Elizabeth, Barriere, Steven L., Kitt, Michael M., Cabell, Christopher H., Corey, G. Ralph
• Format: Article
• Language: English
• Subjects: Adult; Aminoglycosides - adverse effects; Aminoglycosides - therapeutic use; Anti-Bacterial Agents - adverse effects; Anti-Bacterial Agents - therapeutic use; Antibacterial agents; Antibiotics. Antiinfectious agents. Antiparasitic agents; Antimicrobials; Bacteriology; Biological and medical sciences; Dosage; Double-Blind Method; Drug therapy; Epidemiology; Female; Gram positive bacterial infections; Gram-positive bacteria; Gram-Positive Bacterial Infections - drug therapy; Gram-Positive Bacterial Infections - microbiology; Humans; Infections; Major Articles; Male; Medical cures; Medical sciences; Medical treatment; Medications; Methicillin resistant staphylococcus aureus; Middle Aged; Pathogens; Penicillins - adverse effects; Penicillins - therapeutic use; Pharmacology. Drug treatments; Skin Diseases, Bacterial - drug therapy; Skin Diseases, Bacterial - microbiology; Soft Tissue Infections - drug therapy; Soft Tissue Infections - microbiology; Staphylococcus aureus; Vancomycin - adverse effects; Vancomycin - therapeutic use
• ISSN: 1058-4838; 1537-6591
• DOI: 10.1086/429914

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 ⩾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 (⩽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 (∼5%). Fewer serious adverse events were reported in the telavancin group (4 events) than were for the standard therapy group (9). Conclusion Clinical and microbiological results of this study support the further development of telavancin, especially for treatment of infection due to MRSA.