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

Debio 1450-BJI-205

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).

2019-02-20

2026-12-01

2026-12-01

Recruiting

Early phase I

111

Key Inclusion Criteria: * Able to provide written informed consent and to comply with study procedures. * Diagnosis of bone or joint infection which fulfils 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, and, d) Infection is not associated with an ischiatic or a sacral osteomyelitis; and e) Infection can involve periosteal or soft tissue. 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: 1. Severe peripheral arterial disease (PAD) requiring revascularization; however, patients with peripheral artery disease are eligible for inclusion, provided they have undergone successful revascularization or it has been deemed unnecessary by a vascular surgeon 2. Necrotizing fasciitis or gangrene requiring complete lower extremity amputation (of all infected bone and soft tissue). 3. Patients with Charcot foot (suspected neuro-osteoarthropathy according to Investigator's judgment). 4. Need for digital amputation. * Life expectancy of less than 1 year.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 111, 'type': 'ESTIMATED'}}

2024-05-09