- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00974493
Oral Versus Intravenous Antibiotics for Bone and Joint Infections (OVIVA B&J) (OVIVA)
Randomized Open Label Study of Oral Versus Intravenous Antibiotic Treatment for Bone and Joint Infections Requiring Prolonged Antibiotic Treatment: Multi-centre Study
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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Oxfordshire
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Oxford, Oxfordshire, United Kingdom, OX3 7LD
- Nuffield Orthopaedic Centre
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Oxford, Oxfordshire, United Kingdom, OX3 9DU
- Oxford Radcliffe Hospitals Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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;
- Native osteomyelitis.
- Native joint septic arthritis.
- Diabetic foot infection with osteomyelitis.
- Prosthetic joint associated infection.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: Oral antibiotics
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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.
Other Names:
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Active Comparator: Intravenous antibiotics
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Frequency of Definite Failure of Infection Treatment.
Time Frame: 1 year
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Number of participants with definite failure of infection treatment defined by microbiological, histological and clinical criteria and assessed by an independent blinded endpoint committee
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1 year
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Collaborators and Investigators
Investigators
- Principal Investigator: Philip Bejon, PhD, Oxford Radcliffe Hospitals Trust
- Principal Investigator: Matthew Scarborough, MB BS, Oxford University Hospitals
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OVIVA
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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