Study to Assess Safety, Tolerability and Efficacy of Afabicin in The Treatment of Participants With Bone or Joint Infection Due to Staphylococcus
| Status: | Recruiting |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/31/2019 |
| Start Date: | February 20, 2019 |
| End Date: | November 1, 2019 |
| Contact: | Debiopharm International S.A |
| Email: | clinicaltrials@debiopharm.com |
| Phone: | +41 21 321 01 11 |
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
This is an open-label study to assess the safety and tolerability 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).
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).
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.
We found this trial at
2
sites
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