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21 March 2013
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| [ Print-friendly version ] |
| Oral vs Intravenous Antibiotics (OVIVA) for Bone and Joint Infection |
| ISRCTN | ISRCTN91566927 |
| DOI | 10.1186/ISRCTN91566927 |
| ClinicalTrials.gov identifier | NCT00974493 |
| EudraCT number | |
| Public title | Oral vs Intravenous Antibiotics (OVIVA) for Bone and Joint Infection |
| Scientific title | Randomised open label study of oral versus intravenous antibiotic treatment for bone and joint infections requiring prolonged antibiotic treatment: Multi-centre study |
| Acronym | OVIVA |
| Serial number at source | 13780 |
| Study hypothesis |
A long course of antibiotic therapy given intravenously (i.e. by injection or via a ""drip"") is the 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) programs have been established in many centres to deliver intravenous antibiotics safely and conveniently. The majority of patients referred to OPAT programs 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 and 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 randomised to an oral or intravenous ""strategy,"" rather than to individual antibiotics. Patients will be followed up carefully by trial staff for a year; clinical follow up beyond this point may still be required outside the context of the trial. Outcomes will be determined by pre-established objective criteria for treatment failure. We will also look for differences between the two groups in terms of quality of life, side effect profile, frequency of complications, cost and adherence to prescribed antibiotics. More details can be found at: http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=13780 More details can be found at: http://www.hta.ac.uk/2934 |
| Lay summary | Not provided at time of registration |
| Ethics approval | Oxford REC B, 8th January 2013, ref: 13/SC/0016 |
| Study design | Multi-centre randomised open label study |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Bone and joint infection |
| Participants - inclusion criteria |
1. A clinical syndrome comprising any of the following
1.1. Localized pain OR 1.2. Localized inflammation OR 1.3. Temperature >38.0ºC OR 1.4. A discharging wound AND 2. Willing and able to give informed consent 3. Male and female aged 18 years or above 4. The patient has received 7 days or less of intravenous therapy after an appropriate surgical intervention to treat bone or joint infection (regardless of pre-surgical antibiotics) or, if no surgical intervention is required, the patient has received 7 days or less of intravenous therapy after the start of the relevant clinical episode. 5. Has a life expectancy > 1 year 6. Has a bone and joint infection in one of the following categories 6.1. Native osteomyelitis (i.e., bone infection without metal implants such as artificial joints) affecting limb bone, skull, foot or other site OR 6.2. Native joint infection treated by surgical excision OR 6.3. Prosthetic joint infection treated by debridement and retention of the prosthesis, by one stage exchange of the prosthesis or by excision of the prosthetic joint (with or without planned re-implantation) OR 6.4. Orthopaedic device or bone-graft infection treated by debridement and retention, or by debridement and removal OR 6.5. Spinal infection |
| Participants - exclusion criteria |
1. Staphylococcus aureus bacteraemia (blood stream infection) on presentation or within the last 1 month
2. Bacterial endocarditis (heart valve infection) on presentation or within the last month (NB there are no study mandated investigations. Participants are not required to have echocardiograms, blood cultures, or any other investigations to exclude endocarditis in the absence of a clinical indication) 3. Any other concomitant infection which, in the opinion of the clinician responsible for the patient, required a prolonged intravenous course of antibiotics (e.g. central nervous system infection) 4. Mild osteomyelitis, defined as osteomyelitis which, in the opinion of the clinical investigator, would not usually require a 6 week course of intravenous antibiotics 5. An infection for which there are no suitable antibiotic choices to permit randomization between the two arms of the trial (for instance, where organisms are only sensitive to intravenous antibiotics, which occurred in <5% of patients during recruitment for our pilot study) 6. Previous enrolment in the trial 7. Septic shock or systemic features requiring intravenous antibiotics in the opinion of the treating clinician (the patient may be re-evaluated if these features resolve) 8. The patient is unlikely to comply with trial requirements following randomization (including specific requirement for PO or IV course) in the opinion of the investigator 9. There is laboratory evidence of mycobacterial (e.g. tuberculosis), fungal, parasitic or viral etiology 10. The patient is receiving an investigational medical product as part of another clinical trial. |
| Anticipated start date | 01/03/2013 |
| Anticipated end date | 28/02/2016 |
| Status of trial | Ongoing |
| Patient information material | |
| Target number of participants | UK Sample Size: 1050 |
| Interventions |
Route of antibiotic administration, Patients will be randomised to either oral or intravenous antibiotics for the treatment of bone or joint infection
Follow Up Length: 12 month(s) |
| Primary outcome measure(s) | Treatment failure; Timepoint(s): Recurrence of infection within one year of randomisation |
| Secondary outcome measure(s) | No secondary outcome measures |
| Sources of funding | NIHR Health Technology Assessment Programme - HTA (UK) (11/36/29) |
| Trial website | |
| Publications | |
| Contact name | Mrs Cushla Cooper |
| Address | Windmill Road |
| City/town | Oxford |
| Zip/Postcode | OX3 7LD |
| Country | United Kingdom |
| cushla.cooper@ndorms.ox.ac.uk | |
| Sponsor | Oxford Radcliffe Hospitals NHS Trust (UK) |
| Address |
Headley Way
Headington |
| City/town | Oxford |
| Zip/Postcode | OX3 9DU |
| Country | United Kingdom |
| Sponsor website: | http://www.oxfordradcliffe.nhs.uk/home.aspx |
| Date applied | 12/02/2013 |
| Last edited | 19/02/2013 |
| Date ISRCTN assigned | 14/02/2013 |
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| © 2013 ISRCTN unless otherwise stated. | |
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