Once-weekly dalbavancin versus standard-of-care antimicrobial regimens for treatment of skin and soft-tissue infections.
Dalbavancin, a novel glycopeptide with a long elimination half-life ( approximately 9-12 days), was compared to standard antimicrobial therapy for skin and soft-tissue infections (SSTIs). In a randomized, controlled, open-label, phase 2 proof-of-concept trial, adults received 1100 mg of dalbavancin (as a single intravenous infusion), 1000 mg of dalbavancin intravenously and then 500 mg intravenously 1 week later, or a prospectively defined standard-of-care regimen. A gram-positive pathogen was isolated from samples obtained from 41 (66%) of 62 patients at baseline; Staphylococcus aureus was the most prevalent species (83% of pathogens). Clinical success rates at a follow-up visit (test of cure) were 94.1% among patients treated with 2 doses of dalbavancin, 61.5% among patients treated with 1 dose of dalbavancin, and 76.2% among patients treated with a standard-of-care regimen. All treatment regimens were well tolerated; drug-related adverse reaction rates were similar across the 3 groups. These findings suggest that a regimen of 2 doses of dalbavancin administered 1 week apart is effective in the treatment of complicated, gram-positive bacterial SSTIs and warrants further study.
Vicuron Pharmaceuticals, King of Prussia, Pennsylvania, USA. eseltzer@vicuron.com
Elyse
E
Seltzer
Mary Beth
MB
Dorr
Beth P
BP
Goldstein
Marc
M
Perry
James A
JA
Dowell
Tim
T
Henkel
D000328:Adult; D000890:Anti-Infective Agents / Q000009:adverse effects / Q000627:therapeutic use*; D004361:Drug Tolerance; D005260:Female; D006020:Glycopeptides / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D012874:Skin Diseases, Infectious / Q000188:drug therapy* / Q000382:microbiology; D018461:Soft Tissue Infections / Q000188:drug therapy* / Q000382:microbiology; D013211:Staphylococcus aureus; D017334:Teicoplanin / Q000031:analogs & derivatives; D016896:Treatment Outcome
D000890:Anti-Infective Agents; D006020:Glycopeptides; D017334:Teicoplanin; C469289:dalbavancin