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

NCT ID: NCT00974493

Last Updated: 2020-06-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 1054 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2017-02-28

Brief 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.

Detailed Description

A long course of antibiotic therapy given by a "drip" (i.e. intravenous) is recommended treatment for many serious bacterial infections. It is costly and inconvenient for the patient to remain hospitalised for therapy, so outpatient antibiotic therapy (OPAT) programmes have been established in many countries to deliver intravenous antibiotics safely and conveniently. The majority of patients referred to OPAT programmes have bone and joint infections. However, there is no clear evidence that bone and joint infection really require long courses of intravenous antibiotics rather than oral antibiotics.

We will compare the outcome of treatment with intravenous versus oral antibiotic therapy for patients with bone and joint infection. The choice of antibiotic is complex, and antibiotics that are suitable oral choices are often not suitable intravenous choices and vice versa. Subjects will therefore be randomized to an oral or intravenous "strategy," rather than to individual antibiotics. Outcomes will be determined by pre-established objective criteria for treatment failure.

We have conducted a pilot study in one centre (Oxford), recruiting approximately 200 patients, and are now expanding to include multi-centre recruitment in the UK, aiming to recruit 1050 patients.

Conditions

Bone Infection; Joint Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Oral antibiotics

Group Type: ACTIVE_COMPARATOR

Antibiotics

Intervention Type: DRUG

The trial protocol does not specify individual antibiotics, as the trial question is one of strategy (i.e. oral vs intravenous route) rather than individual antibiotics.

Within allocated strategy (i.e. oral or intravenous) antibiotics will be selected by a clinician with reference to the subject's clinical condition, microbiological data and local guidelines.

Intravenous antibiotics

Group Type: ACTIVE_COMPARATOR

Antibiotics

Intervention Type: DRUG

The trial protocol does not specify individual antibiotics, as the trial question is one of strategy (i.e. oral vs intravenous route) rather than individual antibiotics.

Within allocated strategy (i.e. oral or intravenous) antibiotics will be selected by a clinician with reference to the subject's clinical condition, microbiological data and local guidelines.

Interventions

Antibiotics

The trial protocol does not specify individual antibiotics, as the trial question is one of strategy (i.e. oral vs intravenous route) rather than individual antibiotics.

Within allocated strategy (i.e. oral or intravenous) antibiotics will be selected by a clinician with reference to the subject's clinical condition, microbiological data and local guidelines.

Intervention Type: DRUG

Other Intervention Names

Individual antibiotics not specified by protocol

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oxford University Hospitals NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Matthew Scarborough

Primary Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Philip Bejon, PhD

Role: PRINCIPAL_INVESTIGATOR

Oxford Radcliffe Hospitals Trust

Matthew Scarborough, MB BS

Role: PRINCIPAL_INVESTIGATOR

Oxford University Hospitals

Locations

Nuffield Orthopaedic Centre

Oxford, Oxfordshire, United Kingdom

Oxford Radcliffe Hospitals Trust

Oxford, Oxfordshire, United Kingdom

Countries

United Kingdom

Other Identifiers

OVIVA

Identifier Type: -

Identifier Source: org_study_id