Summary

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

Description

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).

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

Keywords

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

Eligibility

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.

Locations

  • Augusta University withdrawn
    Augusta Georgia 30912 United States
  • Wake Forest University Baptist Medical Center withdrawn
    Winston-Salem North Carolina 27157 United States
  • Regional Clinical Hospital under Ivano-Frankivsk Regional Council accepting new patients
    Ivano-Frankivs'k 76008 Ukraine
  • Kharkiv Regional Clinical Traumatology Hospital in progress, not accepting new patients
    Kharkiv 61176 Ukraine
  • Institute of Traumatology and Orthopedics accepting new patients
    Kyiv 01601 Ukraine
  • Kyiv Regional Clinical Hospital in progress, not accepting new patients
    Kyiv 04107 Ukraine
  • Vinnytsya Regional Clinical Hospital accepting new patients
    Vinnytsia 21028 Ukraine
  • Lviv Regional Hospital of Veterans of Wars and Repressed after Yurii Lypa accepting new patients
    Vynnyky 79495 Ukraine
  • City Hospital #9 under Zaporizhia City Council in progress, not accepting new patients
    Zaporizhia 69065 Ukraine

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Debiopharm International SA
Links
Sign up for this study
ID
NCT03723551
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 111 study participants
Last Updated