Study to Assess Safety, Tolerability and Efficacy of Afabicin in The Treatment of Participants With Bone or Joint Infection Due to Staphylococcus
- Conditions
- Bone or Joint Infection
- Registration Number
- NCT03723551
- Lead Sponsor
- Debiopharm International SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 111
Key Inclusion Criteria:<br><br> - Able to provide written informed consent and to comply with study procedures.<br><br> - Diagnosis of bone or joint infection which fulfils the following conditions: a)<br> Infection is due to S. aureus (MSSA or MRSA) and/or CoNS only; and, b) Participants<br> had received no more than 7 days of empiric antibiotics prior to initiating<br> treatment with study drug unless the pathogen isolated was resistant to the<br> administered empiric antibiotics; and, c) Biofilm is not considered to be yet<br> established and/or has been mechanically eradicated; and, d) Infection is not<br> associated with an ischiatic or a sacral osteomyelitis; and e) Infection can involve<br> periosteal or soft tissue.<br><br>Key Exclusion Criteria:<br><br> - Presence of co-infection with non-staphylococcal bacteria at the affected joint or<br> bone site, or in the blood.<br><br> - Participants at an increased risk of developing liver injury.<br><br> - Participants who have medical conditions that increase the risk of QT prolongation.<br><br> - Medical history within the previous 3 months of: myocardial infarction, unstable<br> angina pectoris, coronary artery or cerebral revascularization procedure or stroke,<br> ventricular tachycardia, multifocal ventricular ectopics requiring treatment, or any<br> other clinically relevant symptomatic ventricular arrhythmias.<br><br> - Documented history of alcohol or drug abuse within the previous 12 months.<br><br> - For patients with DFO:<br><br> 1. Severe peripheral arterial disease (PAD) requiring revascularization; however,<br> patients with peripheral artery disease are eligible for inclusion, provided<br> they have undergone successful revascularization or it has been deemed<br> unnecessary by a vascular surgeon<br><br> 2. Necrotizing fasciitis or gangrene requiring complete lower extremity amputation<br> (of all infected bone and soft tissue).<br><br> 3. Patients with Charcot foot (suspected neuro-osteoarthropathy according to<br> Investigator's judgment).<br><br> 4. Need for digital amputation.<br><br> - Life expectancy of less than 1 year.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Based on Nature, Incidence, Severity, Seriousness, and Outcome;Change from Baseline in Number of Participants With Incidence of Laboratory Abnormalities
- Secondary Outcome Measures
Name Time Method Proportion of Participants With Clinical Response