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

NCT ID: NCT03723551

Last Updated: 2025-12-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-20
• Study Completion Date: 2025-04-23

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).

Conditions

Bone or Joint Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Afabicin

Intervention Type: DRUG

Administered intravenously and orally.

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.

Group Type: ACTIVE_COMPARATOR

Standard of Care

Intervention Type: DRUG

Administered with SOC in accordance with local practice and applicable treatment guidelines.

Interventions

Afabicin

Administered intravenously and orally.

Intervention Type: DRUG

Standard of Care

Administered with SOC in accordance with local practice and applicable treatment guidelines.

Intervention Type: DRUG

Eligibility Criteria

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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Debiopharm International SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

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

Countries

Georgia; South Africa; Ukraine

Other Identifiers

Debio 1450-BJI-205

Identifier Type: -

Identifier Source: org_study_id