期刊
ANTIMICROBIAL AGENTS AND CHEMOTHERAPY
卷 62, 期 5, 页码 -出版社
AMER SOC MICROBIOLOGY
DOI: 10.1128/AAC.02580-17
关键词
iclaprim; vancomycin; acute bacterial skin and skin structure infections; skin
资金
- Motif Biosciences plc.
- Basilea Pharmaceutica
- Genentech
- Medicines Company
- Motif Biosciences
- Basilea
- Achaogen
- Abbott Laboratories
- Actelion
- Astellas
- Astra-Zeneca
- Bayer
- Biomerieux
- Cerexa
- Cubist
- Durata
- European Tissue Symposium
- MedImmune
- Merck
- Nabriva
- Optimer
- Paratek
- Pfizer
- Qiagen
- Roche
- Sanofi-Pasteur
- Seres
- Summit
- Synthetic Biologics
- Abbott
- Alere
- Da Volterra
- MicroPharm
- Morphochem AG
- Sharp Dohme Corp.
- Cempra Pharmaceuticals
- PRA International
- Furiex Pharmaceuticals
- Inimex Pharmaceuticals
- Dr. Reddy's Laboratories
- Cubist Pharmaceuticals
- GlaxoSmithKline
- Trius Therapeutics
- ContraFect
- Theravance
- Astellas Pharma
- Innocoll
- Janssen-Cilag
- Cerexa/Forest Laboratories
Iclaprim is a novel diaminopyrimidine antibiotic that may be an effective and safe treatment for serious skin infections. The safety and effectiveness of iclaprim were assessed in a global phase 3, double-blind, randomized, active-controlled trial. Six hundred thirteen adults with acute bacterial skin and skin structure infections (ABSSSIs) suspected or confirmed to be due to Gram-positive pathogens were randomized to iclaprim (80 mg) or vancomycin (15 mg/kg of body weight), both of which were administered intravenously every 12 h for 5 to 14 days. The primary endpoint was a >= 20% reduction in lesion size compared with that at the baseline at 48 to 72 h after the start of administration of study drug in the intent-to-treat population. Among patients randomized to iclaprim, 78.3% (231 of 295) met this primary endpoint, whereas 76.7% (234 of 305) of those receiving vancomycin met this primary endpoint (difference, 1.58%; 95% confidence interval, -5.10% to 8.26%). This met the prespecified 10% noninferiority margin. Iclaprim was well tolerated, with most adverse events being categorized as mild. In conclusion, iclaprim was noninferior to vancomycin in this phase 3 clinical trial for the treatment of acute bacterial skin and skin structure infections. On the basis of these results, iclaprim may be an efficacious and safe treatment for skin infections suspected or confirmed to be due to Gram-positive pathogens.
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