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

Phase 2

Active, not recruiting

• Conditions: Bone or Joint Infection
• Interventions: Drug: Afabicin; 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

Study Timeline

• Study First Submitted: 2018-10-26
• Study First Submitted QC: 2018-10-26
• Study First Posted: 2018-10-29
• Study Start: 2019-02-20
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-20
• Last Update Posted: 2025-06-22
• Primary Completion: 2026-12
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 111

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 & 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

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