drugset / Trial / NCT03723551
Study to Assess Safety, Tolerability and Efficacy of Afabicin in The Treatment of Participants With Bone or Joint Infection Due to Staphylococcus
RandomizedParallel-groupOpen-labelTreatment
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).
Timeline
- Start
- 2019-02-20
- Primary completion
- 2025-04-23
- Completion
- 2025-04-23
Outcome
Outcome not reported
Stopped (Business): “This trial was concluded for strategic reasons.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Afabicin | Small molecule | 80 mg | Intravenous |
| Subject | Afabicin | Small molecule | 240 mg | Intravenous |
| Comparator | Cefazolin | Small molecule | — | Intravenous |
| Comparator | Clindamycin | Unknown | — | Intravenous |
| Comparator | Linezolid | Other / unclassified | — | Intravenous |
| Comparator | Vancomycin | Other / unclassified | — | Intravenous |