NCT03723551

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

Randomized Open-label Active-controlled Study to Assess the Safety, Tolerability, and Efficacy of Afabicin IV/Oral in the Treatment of Patients With Bone or Joint Infection Due to Staphylococcus

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Debiopharm International SA · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Bone or Joint Infection

Interventions

Type	Name	Description
DRUG	Afabicin	Administered intravenously and orally.
DRUG	Standard of Care	Administered with SOC in accordance with local practice and applicable treatment guidelines.

Timeline

• Start date: 2019-02-20
• Primary completion: 2025-04-23
• Completion: 2025-04-23
• First posted: 2018-10-29
• Last updated: 2025-12-01

Locations

19 sites across 3 countries: Georgia, South Africa, Ukraine

Regulatory

• FDA-regulated drug study