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

NCT03723551 | Terminated Phase 2 DMC FDA Drug

• 1 other identifier: Debio 1450-BJI-205
• Study Type: interventional
• Target: 67
• Locations: 3 countries
• Sites: 19

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Proportion of Participants With Clinical Response

  Days 8, 28, 42, EOT, 4-weeks and 12-weeks post- EOT, as applicable up to Day 168

Study Arms (2)

Afabicin

EXPERIMENTAL

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

Standard of Care (SOC) (Parts A and B)

ACTIVE COMPARATOR

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

Interventions

Afabicin DRUG

Administered intravenously and orally.

Afabicin

Standard of Care DRUG

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

Standard of Care (SOC) (Parts A and B)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Debiopharm International SA: lead

Study Sites (19)

Georgian Clinics JSC

Akhalts'ikhe, 0800, Georgia

Location

West Georgia Medical Center LLC

Kutaisi, 4600, Georgia

Location

Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LLC

Tbilisi, 0101, Georgia

Location

LEPL The First University Clinic of Tbilisi State Medical University

Tbilisi, 0141, Georgia

Location

Tbilisi State Medical University And Ingorokva High Medical Technology University Clinic LLC

Tbilisi, 0144, Georgia

Location

Academician Vakhtang Bochorishvili Clinic LTD

Tbilisi, 0160, Georgia

Location

Caucasus Medical Center LLC

Tbilisi, 0186, Georgia

Location

Worthwhile Clinical Trials, Lakeview Hospital

Benoni, 1500, South Africa

Location

Clinical Research Unit, University of Pretoria

Pretoria, 0002, South Africa

Location

Global Clinical Trials (Pty) Ltd

Pretoria, 0157, South Africa

Location

Dnipropetrovsk Regional Clinical Hospital

Dnipro, 49027, Ukraine

Location

Regional Clinical Hospital under Ivano-Frankivsk Regional Council

Ivano-Frankivsk, 76008, Ukraine

Location

Kharkiv Regional Clinical Traumatology Hospital

Kharkiv, 61176, Ukraine

Location

Institute of Traumatology and Orthopedics

Kyiv, 01601, Ukraine

Location

Kyiv Regional Clinical Hospital

Kyiv, 04107, Ukraine

Location

Kyiv City Clinical Hospital #8 under the Executive Body of Kyiv City Council (Kyiv City State Administration)

Kyiv, Ukraine

Location

Vinnytsya Regional Clinical Hospital

Vinnytsia, 21028, Ukraine

Location

Lviv Regional Hospital of Veterans of Wars and Repressed after Yurii Lypa

Vynnyky, 79495, Ukraine

Location

City Hospital #9 under Zaporizhia City Council

Zaporizhia, 69065, Ukraine

Location

MeSH Terms

Interventions

afabicin; Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2018
• First Posted: October 29, 2018
• Study Start: February 20, 2019
• Primary Completion: April 23, 2025
• Study Completion: April 23, 2025
• Last Updated: December 1, 2025

Record last verified: 2025-11

Locations

GE (7); ZA (3); UA (9)