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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
67
Administered intravenously and orally.
Administered with SOC in accordance with local practice and applicable treatment guidelines.
Georgian Clinics JSC
Akhalts'ikhe, Georgia
West Georgia Medical Center LLC
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Based on Nature, Incidence, Severity, Seriousness, and Outcome
Time frame: Baseline up to 12-weeks post- end of treatment (EOT)
Change from Baseline in Number of Participants With Incidence of Laboratory Abnormalities
Time frame: Baseline up to Week 12 post- EOT
Proportion of Participants With Clinical Response
Time frame: Days 8, 28, 42, EOT, 4-weeks and 12-weeks post- EOT, as applicable up to Day 168
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