drugset / Trial / NCT02426918

Study of Debio 1450 for Bacterial Skin Infections

NCT02426918

Phase 2 Completed 330 enrolled Debiopharm International SA
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

EvaluationDrugModalityDoseRoute
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