OVIVA

About this trial

Last updated 5 years ago

Study ID

OVIVA

Status

Completed

Type

Interventional

Phase

Phase 4

Placebo

Accepting

18+ Years

All

Not accepting

Healthy Volunteers

Trial Timing

Ended 8 years ago

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.

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.

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