Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Sacramento, California and other locations
Dates
study started
estimated completion

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, Arthritis, Infectious, Afabicin (Part A), Afabicin (Part B)

Eligibility

You can join if…

Open to people ages 18 years and up

  • Diagnosis of bone or joint infection which fulfills 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.
  • Circulatory shock or any medical condition associated with acute risk of death.
  • Life expectancy of less than 1 year.

Locations

  • UC Davis Health System CTSC Clinical Research Center accepting new patients
    Sacramento California 95817 United States
  • Augusta University accepting new patients
    Augusta Georgia 30912 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 Bone and Joint Infection Research Study
Study Type
Interventional
Participants
Expecting 96 study participants
Last Updated