drugset / Trial / NCT02426918
Study of Debio 1450 for Bacterial Skin Infections
RandomizedParallel-groupDouble-blindTreatment
Summary
The primary objective of this study is to evaluate the efficacy of 2 different doses of intravenous and oral Debio 1450 compared with intravenous vancomycin and oral linezolid in the treatment of patients with staphylococcal ABSSSI.
Timeline
- Start
- 2015-05
- Primary completion
- 2016-08
- Completion
- 2016-09
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Afabicin | Small molecule | 80 mg | Intravenous |
| Subject | Afabicin | Small molecule | 120 mg | Intravenous |
| Subject | Afabicin | Small molecule | 160 mg | Intravenous |
| Subject | Afabicin | Small molecule | 240 mg | Intravenous |
| Comparator | Linezolid | Other / unclassified | 600 mg | Oral |
| Comparator | Vancomycin | Other / unclassified | 15 mg/kg | Intravenous |
| Comparator | Vancomycin | Other / unclassified | 1 g | Intravenous |