TerminatedPhase 2

Study to Assess Safety, Tolerability and Efficacy of Afabicin in The Treatment of Participants With Bone or Joint Infection Due to Staphylococcus

Stopped: This trial was concluded for strategic reasons.

Georgia67 participantsStarted 2019-02-20

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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Exclusion criteria

✕. 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
✕. Necrotizing fasciitis or gangrene requiring complete lower extremity amputation (of all infected bone and soft tissue).
✕. Patients with Charcot foot (suspected neuro-osteoarthropathy according to Investigator's judgment).
✕. Need for digital amputation.

What they're measuring

Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Based on Nature, Incidence, Severity, Seriousness, and Outcome

Timeframe: Baseline up to 12-weeks post- end of treatment (EOT)

Change from Baseline in Number of Participants With Incidence of Laboratory Abnormalities

Timeframe: Baseline up to Week 12 post- EOT

Trial details

NCT IDNCT03723551

SponsorDebiopharm International SA

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-04-23

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