Bone or Joint Infection Clinical Trial
Official title:
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
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).
| Status | Recruiting |
| Enrollment | 111 |
| Est. completion date | March 31, 2026 |
| Est. primary completion date | March 31, 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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, d) Infection is not associated with a diabetic foot; 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. - Life expectancy of less than 1 year. |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | CEMIC | Buenos Aires | |
| Argentina | Italian Hospital of La Plata | Buenos Aires | |
| Argentina | Medical Institute Platense SA | Buenos Aires | |
| Argentina | Cordoba Private University Hospital | Cordoba | |
| Argentina | Hospital Nuestra Senora de la Misericordia | Cordoba | |
| Argentina | Luis Carlos Lagomaggiore Hospital | Mendoza | |
| Argentina | British Sanatorium SA, | Rosario | |
| Argentina | 9 of July Sanatorium | San Miguel De Tucumán | |
| Argentina | Central Clinic S.A. | Villa Regina | |
| South Africa | Worthwhile Clinical Trials, Lakeview Hospital | Benoni | |
| South Africa | JOHESE Clinical Research | Centurion | |
| South Africa | Nelson Mandela Academic Hospital Mthatha | Mthatha | |
| South Africa | Clinical Research Unit, University of Pretoria | Pretoria | |
| South Africa | Global Clinical Trials (Pty) Ltd | Pretoria | |
| South Africa | Mediclinic Victoria | Tongaat | |
| Ukraine | 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 | 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 | |
| United States | Augusta University | Augusta | Georgia |
| United States | Midland Florida Clinical Research Center | DeLand | Florida |
| United States | Wake Forest University Baptist Medical Center | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Debiopharm International SA |
United States, Argentina, South Africa, Ukraine,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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) | ||
| Primary | Change from Baseline in Number of Participants With Incidence of Laboratory Abnormalities | Baseline up to Week 12 post- EOT | ||
| Secondary | Proportion of Participants With Clinical Response | Days 8, 28, 42, EOT, 4-weeks and 12-weeks post- EOT, as applicable up to Day 168 |