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Study to Assess Safety, Tolerability and Efficacy of Afabicin in The Treatment of Participants With Bone or Joint Infection Due to Staphylococcus
Sponsor: Debiopharm International SA
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).
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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
67
Start Date
2019-02-20
Completion Date
2025-04-23
Last Updated
2026-09-09
Healthy Volunteers
No
Conditions
Interventions
Afabicin
Administered intravenously and orally.
Cefazolin
Administered intravenously.
Vancomycin
Administered intravenously.
Linezolid
Administered intravenously and orally.
Clindamycin
Administered intravenously and orally.
Locations (19)
Georgian Clinics JSC
Akhalts'ikhe, 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
Dnipro, Ukraine
Regional Clinical Hospital under Ivano-Frankivsk Regional Council
Ivano-Frankivsk, 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