NCT02569541

Oral Sodium Fusidate (CEM-102) for the Treatment of Staphylococcal Bone or Joint Infections

An Open-Label, Non-Randomized, Single-Arm, Multi-Center Study to Evaluate Oral Sodium Fusidate (CEM-102) for the Treatment of Staphylococcal Bone or Joint Infections in Subjects for Whom Chronic Antibiotic Suppressive Therapy is Indicated

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Arrevus Inc. · Industry
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the safety and effectiveness of oral sodium fusidate (CEM-102) as chronic antibiotic for the treatment of bone or joint infections.

Detailed description

Prospective, open-label, non-randomized, single-arm trial to evaluate the safety and effectiveness of CEM-102 for chronic antibiotic suppressive therapy of bone or joint infections. Subjects enrolling in this study must have a refractory staphylococcal bone or joint infection that requires suppressive antibiotic therapy (e.g. having an infection that cannot be managed by complete removal of the infected bone or foreign material, a refractory infection not responding to previous treatment, or not being a candidate for long-term intravenous antibiotic therapy).

Conditions

• Refractory Bone or Joint Infections

Interventions

Type	Name	Description
DRUG	sodium fusidate

Timeline

• Start date: 2015-12-01
• Primary completion: 2017-10-17
• Completion: 2019-02-21
• First posted: 2015-10-06
• Last updated: 2020-01-30
• Results posted: 2020-01-30

Locations

19 sites across 1 country: United States

Regulatory

• FDA-regulated drug study