for people ages 18 years and up (full criteria)
at Augusta, Georgia and other locations
study started
completion around



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).

Official Title

Randomized Open-label Active-controlled Study to Assess the Safety, Tolerability, and Efficacy of Afabicin IV/Oral in the Treatment of Patients With Bone or Joint Infection Due to Staphylococcus


Bone or Joint Infection, Infections, Communicable Diseases, Infectious Arthritis, Afabicin


You can join if…

Open to people ages 18 years and up

  • 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 CAN'T join 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:
    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.


  • Augusta University accepting new patients
    Augusta Georgia 30912 United States
  • Wake Forest University Baptist Medical Center withdrawn
    Winston-Salem North Carolina 27157 United States
  • CEMIC accepting new patients
    Buenos Aires Argentina
  • Hospital Nuestra Senora de la Misericordia withdrawn
    Cordoba X5000 Argentina
  • Cordoba Private University Hospital withdrawn
    Cordoba X5016KEH Argentina
  • Luis Carlos Lagomaggiore Hospital accepting new patients
    Mendoza 5500 Argentina
  • British Sanatorium SA, withdrawn
    Rosario S2000CVB Argentina
  • 9 of July Sanatorium accepting new patients
    San Miguel De Tucumán 4000 Argentina
  • Central Clinic S.A. withdrawn
    Villa Regina 8336 Argentina


accepting new patients
Start Date
Completion Date
Debiopharm International SA
Sign up for this study
Phase 2 research study
Study Type
Expecting 111 study participants
Last Updated