Bone InfectionPhase 4OVIVANCT00974493
Oral Versus Intravenous Antibiotics for Bone and Joint Infections (OVIVA B&J)
A Phase 4 study testing Antibiotics in people with Bone Infection and Joint Infection, run by Oxford University Hospitals NHS Trust at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Infection, Joint Infection
- What is being tested?
- Antibiotics
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,054 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Jun 2010to 28 Feb 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- Has Staph aureus bacteraemia.
- Has suspected bacterial endocarditis.
- Has suspected mediastinal infection.
- Has suspected central nervous system infection.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Nuffield Orthopaedic Centre
Oxford, Oxfordshire, OX3 7LD
Oxford Radcliffe Hospitals Trust
Oxford, Oxfordshire, OX3 9DU
About this study
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 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.
Read the 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
- Being tested
- Antibiotics
- Keywords
- oral, intravenous, antibiotics, bone, joint, infection
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AntibioticsDrug
Also called Individual antibiotics not specified by protocol
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.
| Study group | Role | What they receive |
|---|---|---|
| Oral antibiotics | Active comparator | Not described Receives: Drug: Antibiotics |
| Intravenous antibiotics | Active comparator | Not described Receives: Drug: Antibiotics |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Frequency of Definite Failure of Infection Treatment.
Number of participants with definite failure of infection treatment defined by microbiological, histological and clinical criteria and assessed by an independent blinded endpoint committee
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2009 (estimated)
- Study startJun 2010
- Primary completionMar 2013
- Study completion28 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Bone InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,054 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford University Hospitals NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Scarborough, Oxford University Hospitals NHS Trust
- Investigators
- Philip Bejon, PhD, Principal investigator, Oxford Radcliffe Hospitals TrustMatthew Scarborough, MB BS, Principal investigator, Oxford University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00974493
- Sponsor's protocol ID
- OVIVA
- Acronym
- OVIVA
- Status last verified
- Jun 2020
- First submitted
- 4 Sep 2009
- Last updated
- 5 Jun 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Open Label Study of Oral Versus Intravenous Antibiotic Treatment for Bone and Joint Infections Requiring Prolonged Antibiotic Treatment: Multi-centre Study
- ClinicalTrials.gov ID
- NCT00974493
- Acronym / sponsor ID
- OVIVA / OVIVA
- Conditions
- Bone Infection, Joint Infection
- Keywords
- oral, intravenous, antibiotics, bone, joint, infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,054 participants (actual)
- Lead sponsor
- Oxford University Hospitals NHS TrustUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Mar 2013 (actual)
- Study completion
- 28 Feb 2017 (actual)
- First posted
- 10 Sep 2009 (estimated)
- Results
- Posted 5 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral antibiotics | Active comparator | Drug: Antibiotics |
| Intravenous antibiotics | Active comparator | Drug: Antibiotics |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Is willing and able to give informed consent for participation in the study. Has a bone and joint infection one of the following categories;
- 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.
Key exclusion criteria (4 listed)
- Has Staph aureus bacteraemia.
- Has suspected bacterial endocarditis.
- Has suspected mediastinal infection.
- Has suspected central nervous system infection.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AntibioticsAlso: Individual antibiotics not specified by protocolThe 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. | Drug | Intravenous antibiotics, Oral antibiotics |
Primary outcome
The Frequency of Definite Failure of Infection Treatment.
Time frame: 1 year
Number of participants with definite failure of infection treatment defined by microbiological, histological and clinical criteria and assessed by an independent blinded endpoint committee
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Bejon, PhD principal investigator
Oxford Radcliffe Hospitals Trust
Matthew Scarborough, MB BS principal investigator
Oxford University Hospitals
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Antibiotics in people with Bone Infection and Joint Infection, run by Oxford University Hospitals NHS Trust at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Frequency of Definite Failure of Infection Treatment. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2020.