Oral Versus Intravenous Antibiotics for Bone and Joint Infections (OVIVA B&J)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Bone Infection Joint Infection |
Drug: Antibiotics |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Randomized Open Label Study of Oral Versus Intravenous Antibiotic Treatment for Bone and Joint Infections Requiring Prolonged Antibiotic Treatment: Multi-centre Study |
- The frequency of definite failure of infection treatment, defined by objective criteria. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Possible failure of infection treatment (specified in detail in the protocol). [ Time Frame: 1 year ] [ Designated as safety issue: No ]
- Frequency and severity of adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 1050 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Oral antibiotics |
Drug: 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. Other Name: Individual antibiotics not specified by protocol
|
| Active Comparator: Intravenous antibiotics |
Drug: 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. Other Name: Individual antibiotics not specified by protocol
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| United Kingdom | |
| Oxford Radcliffe Hospitals Trust | |
| Oxford, Oxfordshire, United Kingdom, OX3 9DU | |
| Nuffield Orthopaedic Centre | |
| Oxford, Oxfordshire, United Kingdom, OX3 7LD | |
| Principal Investigator: | Philip Bejon, PhD | Oxford Radcliffe Hospitals Trust |
| Principal Investigator: | Matthew Scarborough, MB BS | Oxford University Hospitals |
More Information
No publications provided
| Responsible Party: | Philip Bejon, PI, Oxford University Hospitals NHS Trust |
| ClinicalTrials.gov Identifier: | NCT00974493 History of Changes |
| Other Study ID Numbers: | OVIVA |
| Study First Received: | September 4, 2009 |
| Last Updated: | November 13, 2012 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency United Kingdom: National Health Service United Kingdom: Research Ethics Committee |
Keywords provided by Oxford University Hospitals NHS Trust:
|
oral intravenous antibiotics |
bone joint infection |
Additional relevant MeSH terms:
|
Osteomyelitis Arthritis, Infectious Bone Diseases, Infectious Infection Bone Diseases Musculoskeletal Diseases |
Arthritis Joint Diseases Anti-Bacterial Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013