Overview

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

Status:
Recruiting

Trial end date:
2022-10-31

Target enrollment:
0

Participant gender:
All

Summary

This is an open-label study to assess the safety and tolerability 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).

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Debiopharm International SA

Criteria

Inclusion Criteria:

- Diagnosis of bone or joint infection which fulfills the following conditions: a)
Infection is due to S. aureus (MSSA or MRSA) and/or CoNS only; and, b) Participants
had received no more than 7 days of empiric antibiotics prior to initiating treatment
with study drug unless the pathogen isolated was resistant to the administered empiric
antibiotics; and, c) Biofilm is not considered to be yet established and/or has been
mechanically eradicated; and, d) Infection is not associated with a diabetic foot;
and, e) Infection can involve periosteal or soft tissue.

Exclusion Criteria:

- Presence of co-infection with non-staphylococcal bacteria at the affected joint or
bone site, or in the blood.

- Participants at an increased risk of developing liver injury.