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
Who is this study for? Patients with bone or joint infection due to Staphylococcus aureus
What treatments are being studied? Afabicin
Status: Terminated
Location: See all (19) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Georgia
Georgian Clinics JSC
Akhalts'ikhe
West Georgia Medical Center LLC
Kutaisi
Academician Vakhtang Bochorishvili Clinic LTD
Tbilisi
Caucasus Medical Center LLC
Tbilisi
LEPL The First University Clinic of Tbilisi State Medical University
Tbilisi
Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LLC
Tbilisi
Tbilisi State Medical University And Ingorokva High Medical Technology University Clinic LLC
Tbilisi
South Africa
Worthwhile Clinical Trials, Lakeview Hospital
Benoni
Clinical Research Unit, University of Pretoria
Pretoria
Global Clinical Trials (Pty) Ltd
Pretoria
Ukraine
Dnipropetrovsk Regional Clinical Hospital
Dnipro
Regional Clinical Hospital under Ivano-Frankivsk Regional Council
Ivano-frankivsk
Kharkiv Regional Clinical Traumatology Hospital
Kharkiv
Institute of Traumatology and Orthopedics
Kyiv
Kyiv City Clinical Hospital #8 under the Executive Body of Kyiv City Council (Kyiv City State Administration)
Kyiv
Kyiv Regional Clinical Hospital
Kyiv
Vinnytsya Regional Clinical Hospital
Vinnytsia
Lviv Regional Hospital of Veterans of Wars and Repressed after Yurii Lypa
Vynnyky
City Hospital #9 under Zaporizhia City Council
Zaporizhia
Time Frame
Start Date:2019-02-20
Completion Date:2025-04-23
Participants
Target number of participants:67
Treatments
Experimental: 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.
Active_comparator: Standard of Care (SOC) (Parts A and B)
Participants will be administered with SOC in accordance with local practice and applicable treatment guidelines without exceeding the maximum dosing schedule.