drugset
drugset / Trial / NCT03723551

Study to Assess Safety, Tolerability and Efficacy of Afabicin in The Treatment of Participants With Bone or Joint Infection Due to Staphylococcus

NCT03723551 ↗

Phase 2 Terminated 67 enrolled Debiopharm International SA
RandomizedParallel-groupOpen-labelTreatment

Summary

This is a randomized, active-controlled, open-label study to assess the safety, tolerability and efficacy of Afabicin in the treatment of participants with bone or joint infection due to Staphylococcus aureus \[both methicillin-susceptible S. aureus (MSSA) and methicillin-resistant S. aureus (MRSA)\] and/or coagulase-negative staphylococci (CoNS) and to compare it to standard of care (SOC).

Timeline

Start
2019-02-20
Primary completion
2025-04-23
Completion
2025-04-23

Drugs

EvaluationDrugModalityDoseRoute
Subject Afabicin Small molecule 80 mg Intravenous
Subject Afabicin Small molecule 120 mg Intravenous
Subject Afabicin Small molecule 240 mg Intravenous

Indications

infectious disease