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New antibiotic afabicin tested for tough bone infections – but trial stopped early

NCT ID NCT03723551

Disease control Sponsor: Debiopharm International SA Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 09, 2026 · Updated 3 times

Summary

This study tested a new antibiotic called afabicin in 67 people with bone or joint infections caused by staph bacteria. The goal was to see if afabicin is safe and works as well as standard antibiotics. However, the trial was stopped early, so the full results are not available.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
afabicin
What this could lead to
If successful, afabicin could offer a new antibiotic option for treating stubborn staph infections in bones or joints.
What could go wrong
This was a small, early-stage (Phase 2) trial that was terminated, so we don't have complete results. It's unclear if afabicin works better than current treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

67 people

The number who actually took part.

Started

Feb 2019

Finished

Apr 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bone or joint infection

Contacts and locations

Locations

  • Academician Vakhtang Bochorishvili Clinic LTD

    Tbilisi, 0160, Georgia

  • Caucasus Medical Center LLC

    Tbilisi, 0186, Georgia

  • City Hospital #9 under Zaporizhia City Council

    Zaporizhia, 69065, Ukraine

  • Clinical Research Unit, University of Pretoria

    Pretoria, 0002, South Africa

  • Dnipropetrovsk Regional Clinical Hospital

    Dnipro, 49027, Ukraine

  • Georgian Clinics JSC

    Akhalts'ikhe, 0800, Georgia

  • Global Clinical Trials (Pty) Ltd

    Pretoria, 0157, South Africa

  • Institute of Traumatology and Orthopedics

    Kyiv, 01601, Ukraine

  • Kharkiv Regional Clinical Traumatology Hospital

    Kharkiv, 61176, Ukraine

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

    Kyiv, Ukraine

  • Kyiv Regional Clinical Hospital

    Kyiv, 04107, Ukraine

  • LEPL The First University Clinic of Tbilisi State Medical University

    Tbilisi, 0141, Georgia

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

    Vynnyky, 79495, Ukraine

  • Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LLC

    Tbilisi, 0101, Georgia

  • Regional Clinical Hospital under Ivano-Frankivsk Regional Council

    Ivano-Frankivsk, 76008, Ukraine

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

    Tbilisi, 0144, Georgia

  • Vinnytsya Regional Clinical Hospital

    Vinnytsia, 21028, Ukraine

  • West Georgia Medical Center LLC

    Kutaisi, 4600, Georgia

  • Worthwhile Clinical Trials, Lakeview Hospital

    Benoni, 1500, South Africa