drugset / Trial / NCT01339091
Efficacy and Safety of Dalbavancin for the Treatment of Acute Bacterial Skin and Skin Structure Infections
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The primary object is to compare the early clinical efficacy (after 48-72 hours of therapy) of dalbavancin to the comparator regimen (vancomycin with the option to switch to oral linezolid) for the treatment of patients with a suspected or proven gram-positive bacterial skin or skin structure infection.
Timeline
- Start
- 2011-03
- Primary completion
- 2012-09
- Completion
- 2012-11
Publications
- Gonzalez PL, Rappo U, Akinapelli K, McGregor JS, Puttagunta S, Dunne MW. Outcomes in Patients with Staphylococcus aureus Bacteremia Treated with Dalbavancin in Clinical Trials. Infect Dis Ther. 2022 Feb;11(1):423-434. doi: 10.1007/s40121-021-00568-7. Epub 2021 Dec 14.
- Boucher HW, Wilcox M, Talbot GH, Puttagunta S, Das AF, Dunne MW. Once-weekly dalbavancin versus daily conventional therapy for skin infection. N Engl J Med. 2014 Jun 5;370(23):2169-79. doi: 10.1056/NEJMoa1310480.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Dalbavancin | Other / unclassified | 500 mg | Intravenous |
| Comparator | Linezolid | Other / unclassified | 600 mg | Oral |
| Comparator | Vancomycin | Other / unclassified | 15 mg/kg | Intravenous |
| Comparator | Vancomycin | Other / unclassified | 1 g | Intravenous |