Status and phase
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About
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).
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Inclusion and exclusion criteria
Key Inclusion Criteria:
Key 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.
Participants who have medical conditions that increase the risk of QT prolongation.
Medical history within the previous 3 months of: myocardial infarction, unstable angina pectoris, coronary artery or cerebral revascularization procedure or stroke, ventricular tachycardia, multifocal ventricular ectopics requiring treatment, or any other clinically relevant symptomatic ventricular arrhythmias.
Documented history of alcohol or drug abuse within the previous 12 months.
For patients with DFO:
Life expectancy of less than 1 year.
Primary purpose
Allocation
Interventional model
Masking
111 participants in 2 patient groups
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Central trial contact
Debiopharm International S.A
Data sourced from clinicaltrials.gov
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