Study to Assess Safety, Tolerability and Efficacy of Afabicin in The Treatment of Participants With Bone or Joint Infection Due to Staphylococcus

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).

Study Overview

• Status: Terminated
• Conditions: Bone or Joint Infection
• Intervention / Treatment: Drug: Afabicin; Drug: Standard of Care

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Phase 2

Contacts and Locations

Study Locations

• Georgia
  • Akhalts'ikhe, Georgia, 0800
    • Georgian Clinics JSC
  • Kutaisi, Georgia, 4600
    • West Georgia Medical Center LLC
  • Tbilisi, Georgia, 0141
    • LEPL The First University Clinic of Tbilisi State Medical University
  • Tbilisi, Georgia, 0144
    • Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic LLC
  • Tbilisi, Georgia, 0101
    • Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LLC
  • Tbilisi, Georgia, 0160
    • Academician Vakhtang Bochorishvili Clinic LTD
  • Tbilisi, Georgia, 0186
    • Caucasus Medical Center LLC
• South Africa
  • Benoni, South Africa, 1500
    • Worthwhile Clinical Trials, Lakeview Hospital
  • Pretoria, South Africa, 0002
    • Clinical Research Unit, University of Pretoria
  • Pretoria, South Africa, 0157
    • Global Clinical Trials (Pty) Ltd
• Ukraine
  • Dnipro, Ukraine, 49027
    • Dnipropetrovsk Regional Clinical Hospital
  • Ivano-Frankivsk, Ukraine, 76008
    • Regional Clinical Hospital under Ivano-Frankivsk Regional Council
  • Kharkiv, Ukraine, 61176
    • Kharkiv Regional Clinical Traumatology Hospital
  • Kyiv, Ukraine, 04107
    • Kyiv Regional Clinical Hospital
  • Kyiv, Ukraine, 01601
    • Institute of Traumatology and Orthopedics
  • Kyiv, Ukraine
    • Kyiv City Clinical Hospital #8 under the Executive Body of Kyiv City Council (Kyiv City State Administration)
  • Vinnytsia, Ukraine, 21028
    • Vinnytsya Regional Clinical Hospital
  • Vynnyky, Ukraine, 79495
    • Lviv Regional Hospital of Veterans of Wars and Repressed after Yurii Lypa
  • Zaporizhia, Ukraine, 69065
    • City Hospital #9 under Zaporizhia City Council

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 an ischiatic or a sacral osteomyelitis; 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.

• For patients with DFO:

  1. 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
  2. Necrotizing fasciitis or gangrene requiring complete lower extremity amputation (of all infected bone and soft tissue).
  3. Patients with Charcot foot (suspected neuro-osteoarthropathy according to Investigator's judgment).
  4. Need for digital amputation.
• Life expectancy of less than 1 year.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Standard of Care; Administered with SOC in accordance with local practice and applicable treatment guidelines.
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.	Drug: Afabicin; Administered intravenously and orally.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Proportion of Participants With Clinical Response	Days 8, 28, 42, EOT, 4-weeks and 12-weeks post- EOT, as applicable up to Day 168

Collaborators and Investigators

• Sponsor: Debiopharm International SA

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2019
• Primary Completion (Actual): April 23, 2025
• Study Completion (Actual): April 23, 2025

Study Registration Dates

• First Submitted: October 26, 2018
• First Submitted That Met QC Criteria: October 26, 2018
• First Posted (Actual): October 29, 2018

Study Record Updates

• Last Update Posted (Actual): December 1, 2025
• Last Update Submitted That Met QC Criteria: November 28, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathologic Processes; Disease Attributes; Arthritis; Joint Diseases; Infections; Communicable Diseases; Arthritis, Infectious; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care; afabicin
• Other Study ID Numbers: Debio 1450-BJI-205; 2017-002854-35 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No