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

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    96
  • sponsor
    Debiopharm International SA
Updated on 17 September 2022

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).

Details
Condition Bone or Joint Infection
Treatment Standard of Care, SOC, Afabicin, Afabicin (Part A), Afabicin (Part B)
Clinical Study IdentifierNCT03723551
SponsorDebiopharm International SA
Last Modified on17 September 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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