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

Last updated: June 20, 2025
Sponsor: Debiopharm International SA
Overall Status: Active - Not Recruiting

Phase

2

Condition

N/A

Treatment

Standard of Care

Afabicin

Clinical Study ID

NCT03723551
Debio 1450-BJI-205
2017-002854-35
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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) Participantshad received no more than 7 days of empiric antibiotics prior to initiatingtreatment with study drug unless the pathogen isolated was resistant to theadministered empiric antibiotics; and, c) Biofilm is not considered to be yetestablished and/or has been mechanically eradicated; and, d) Infection is notassociated with an ischiatic or a sacral osteomyelitis; and e) Infection can involveperiosteal or soft tissue.

Exclusion

Key Exclusion Criteria:

  • Presence of co-infection with non-staphylococcal bacteria at the affected joint orbone 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, unstableangina pectoris, coronary artery or cerebral revascularization procedure or stroke,ventricular tachycardia, multifocal ventricular ectopics requiring treatment, or anyother 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, providedthey have undergone successful revascularization or it has been deemedunnecessary 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 toInvestigator's judgment).

  4. Need for digital amputation.

  • Life expectancy of less than 1 year.

Study Design

Total Participants: 111
Treatment Group(s): 2
Primary Treatment: Standard of Care
Phase: 2
Study Start date:
February 20, 2019
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • CEMIC

    Buenos Aires,
    Argentina

    Site Not Available

  • Italian Hospital of La Plata

    Buenos Aires, B1900
    Argentina

    Site Not Available

  • Medical Institute Platense SA

    Buenos Aires, B1900AVG
    Argentina

    Site Not Available

  • Cordoba Private University Hospital

    Cordoba, X5016KEH
    Argentina

    Site Not Available

  • Hospital Nuestra Senora de la Misericordia

    Cordoba, X5000
    Argentina

    Site Not Available

  • Luis Carlos Lagomaggiore Hospital

    Mendoza, 5500
    Argentina

    Site Not Available

  • British Sanatorium SA,

    Rosario, S2000CVB
    Argentina

    Site Not Available

  • 9 of July Sanatorium

    San Miguel De Tucumán, 4000
    Argentina

    Site Not Available

  • Central Clinic S.A.

    Villa Regina, 8336
    Argentina

    Site Not Available

  • Georgian Clinics JSC

    Akhaltsikhe, 0800
    Georgia

    Site Not Available

  • West Georgia Medical Center LLC

    Kutaisi, 4600
    Georgia

    Site Not Available

  • Academician Vakhtang Bochorishvili Clinic LTD

    Tbilisi, 0160
    Georgia

    Site Not Available

  • Caucasus Medical Center LLC

    Tbilisi, 0186
    Georgia

    Site Not Available

  • LEPL The First University Clinic of Tbilisi State Medical University

    Tbilisi, 0141
    Georgia

    Site Not Available

  • Malkhaz Katsiashvili Multiprofile Emergency Medicine Center LLC

    Tbilisi, 0101
    Georgia

    Site Not Available

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

    Tbilisi, 0144
    Georgia

    Site Not Available

  • Global Clinical Trials (Pty) Ltd

    Arcadia, 0001
    South Africa

    Site Not Available

  • Worthwhile Clinical Trials, Lakeview Hospital

    Benoni, 1500
    South Africa

    Site Not Available

  • JOHESE Clinical Research

    Centurion, 1692
    South Africa

    Site Not Available

  • Walk-a-Mile Centre for Advanced Orthopaedics

    Centurion, 1692
    South Africa

    Site Not Available

  • Nelson Mandela Academic Hospital Mthatha

    Mthatha, 5099
    South Africa

    Site Not Available

  • Clinical Research Unit, University of Pretoria

    Pretoria, 0002
    South Africa

    Site Not Available

  • Global Clinical Trials (Pty) Ltd

    Pretoria, 0157
    South Africa

    Site Not Available

  • Steve Biko Academic Hospital

    Pretoria, 0002
    South Africa

    Site Not Available

  • Mediclinic Victoria

    Tongaat, 4400
    South Africa

    Site Not Available

  • Cherkasy Regional Hospital of Cherkasy Oblast Council

    Cherkasy, 18009
    Ukraine

    Site Not Available

  • Center for Traumatology and Orthopedics Co Ltd.

    Chernivtsi, 58023
    Ukraine

    Site Not Available

  • Dnipropetrovsk Regional Clinical Hospital

    Dnipropetrovs'k, 49027
    Ukraine

    Site Not Available

  • Regional Clinical Hospital under Ivano-Frankivsk Regional Council

    Ivano-Frankivs'k, 76008
    Ukraine

    Site Not Available

  • Kharkiv City Clinical Hospital #2

    Kharkiv, 61037
    Ukraine

    Site Not Available

  • Kharkiv Regional Clinical Traumatology Hospital

    Kharkiv, 61176
    Ukraine

    Site Not Available

  • Institute of Traumatology and Orthopedics

    Kyiv, 01601
    Ukraine

    Site Not Available

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

    Kyiv,
    Ukraine

    Site Not Available

  • Kyiv Regional Clinical Hospital

    Kyiv, 04107
    Ukraine

    Site Not Available

  • Vinnytsya Regional Clinical Hospital

    Vinnytsia, 21028
    Ukraine

    Site Not Available

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

    Vynnyky, 79495
    Ukraine

    Site Not Available

  • City Hospital #9 under Zaporizhia City Council

    Zaporizhia, 69065
    Ukraine

    Site Not Available

  • UC Davis Health System CTSC Clinical Research Center

    Sacramento, California 95817
    United States

    Site Not Available

  • Midland Florida Clinical Research Center

    DeLand, Florida 32720
    United States

    Site Not Available

  • Midway Immunology and Research Center

    Fort Pierce, Florida 34982
    United States

    Site Not Available

  • Augusta University

    Augusta, Georgia 30912
    United States

    Site Not Available

  • South Jersey Infectious Disease

    Somers Point, New Jersey 08244
    United States

    Site Not Available

  • Sergievsky Center - Columbia University (CUMC)

    New York, New York 10032
    United States

    Site Not Available

  • Wake Forest University Baptist Medical Center

    North Wilkesboro, North Carolina 27157
    United States

    Site Not Available

  • Wake Forest University Baptist Medical Center

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • Oregon Health and Science University

    Portland, Oregon 97239
    United States

    Site Not Available

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