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
- Interventions
- Drug: Standard of Care
- Registration Number
- NCT03723551
- Lead Sponsor
- Debiopharm International SA
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 111
- 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, d) Infection is not associated with an ischiatic or a sacral osteomyelitis; and e) Infection can involve periosteal or soft tissue.
Key
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Presence of co-infection with non-staphylococcal bacteria at the affected joint or bone site, or in the blood.
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Participants at an increased risk of developing liver injury.
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Participants who have medical conditions that increase the risk of QT prolongation.
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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.
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Documented history of alcohol or drug abuse within the previous 12 months.
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For patients with DFO:
- 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
- Necrotizing fasciitis or gangrene requiring complete lower extremity amputation (of all infected bone and soft tissue).
- Patients with Charcot foot (suspected neuro-osteoarthropathy according to Investigator's judgment).
- Need for digital amputation.
-
Life expectancy of less than 1 year.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Afabicin Afabicin In Part A, afabicin will be given intravenous (IV) at a dose 160 milligrams (mg) twice daily (BID) for a minimum of 1 day (at least 1 dose) and up to a maximum of 14 days (2 weeks), followed by a switch to oral Afabicin at a dose of 240 mg BID for the remaining treatment duration. In Part B, participants will be administered with open label afabicin IV at a dose of 55 mg BID for a minimum of 1 day (at least 1 dose) and up to a maximum of 14 days (2 weeks) followed by a switch to oral afabicin at a dose of 80 mg BID for the remaining treatment duration. In certain study conditions a higher dosing regimen of afabicin might be used: afabicin intravenous (IV) at a dose of 80 mg BID for a minimum of 1 day (at least 1 dose) and up to a maximum of 14 days (2 weeks) followed by a switch to oral afabicin at a dose of 120 mg BID for the remaining treatment duration. Standard of Care (SOC) (Parts A and B) Standard of Care Participants will be administered with SOC in accordance with local practice and applicable treatment guidelines without exceeding the maximum dosing schedule.
- 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 Baseline up to 12-weeks post- end of treatment (EOT) Change from Baseline in Number of Participants With Incidence of Laboratory Abnormalities Baseline up to Week 12 post- EOT
- Secondary Outcome Measures
Name Time Method Proportion of Participants With Clinical Response Days 8, 28, 42, EOT, 4-weeks and 12-weeks post- EOT, as applicable up to Day 168
Trial Locations
- Locations (19)
Georgian Clinics JSC
🇬🇪Akhaltsikhe, Georgia
West Georgia Medical Center LLC
🇬🇪Kutaisi, Georgia
Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LLC
🇬🇪Tbilisi, Georgia
LEPL The First University Clinic of Tbilisi State Medical University
🇬🇪Tbilisi, Georgia
Tbilisi State Medical University And Ingorokva High Medical Technology University Clinic LLC
🇬🇪Tbilisi, Georgia
Academician Vakhtang Bochorishvili Clinic LTD
🇬🇪Tbilisi, Georgia
Caucasus Medical Center LLC
🇬🇪Tbilisi, Georgia
Worthwhile Clinical Trials, Lakeview Hospital
🇿🇦Benoni, South Africa
Clinical Research Unit, University of Pretoria
🇿🇦Pretoria, South Africa
Global Clinical Trials (Pty) Ltd
🇿🇦Pretoria, South Africa
Dnipropetrovsk Regional Clinical Hospital
🇺🇦Dnipropetrovs'k, Ukraine
Regional Clinical Hospital under Ivano-Frankivsk Regional Council
🇺🇦Ivano-Frankivs'k, Ukraine
Kharkiv Regional Clinical Traumatology Hospital
🇺🇦Kharkiv, Ukraine
Institute of Traumatology and Orthopedics
🇺🇦Kyiv, Ukraine
Kyiv Regional Clinical Hospital
🇺🇦Kyiv, Ukraine
Kyiv City Clinical Hospital #8 under the Executive Body of Kyiv City Council (Kyiv City State Administration)
🇺🇦Kyiv, Ukraine
Vinnytsya Regional Clinical Hospital
🇺🇦Vinnytsia, Ukraine
Lviv Regional Hospital of Veterans of Wars and Repressed after Yurii Lypa
🇺🇦Vynnyky, Ukraine
City Hospital #9 under Zaporizhia City Council
🇺🇦Zaporizhia, Ukraine