Oral Versus Intravenous Antibiotics for Bone and Joint Infections (OVIVA B&J)

• Status: Completed
• Trial end date: 2017-02-28
• Target enrollment: 0
• Participant gender: All

Summary

The study will compare the outcomes of treating bone and joint infections with 6 weeks of intravenous antibiotics with 6 weeks of oral antibiotic treatment. The trial is of antibiotic "strategy" rather than of individual antibiotics. The study will be open label, but the primary outcome will be proven failure of infection treatment, determined by pre-established objective criteria for treatment failure. The null hypothesis tested is that there will be no difference in treatment failure rates.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oxford University Hospitals NHS Trust
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular

Criteria

Inclusion Criteria:

• Is willing and able to give informed consent for participation in the study. Has a bone and joint infection one of the following categories;

1. Native osteomyelitis.

2. Native joint septic arthritis.

3. Diabetic foot infection with osteomyelitis.

4. Prosthetic joint associated infection.

5. Discitis/ spinal osteomyelitis/ epidural abscess

• Has had at least 48 hours, but not more than 7 days, of IV antibiotic therapy already given after definitive surgical management.

• Has a clinical diagnosis of bacterial infection (caused by any organism excepting mycobacteria).

• Is clinically stable in the opinion of the study clinicians, has no further interventions to treat acute infection required or planned.

Exclusion Criteria:

• Has Staph aureus bacteraemia.

• Has suspected bacterial endocarditis.

• Has suspected mediastinal infection.

• Has suspected central nervous system infection.