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 a diabetic foot; 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.
  • Life expectancy of less than 1 year.

Locations

  • Augusta University accepting new patients
    Augusta Georgia 30912 United States
  • Wake Forest University Baptist Medical Center accepting new patients
    Winston-Salem North Carolina 27157 United States

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