Condition category
Musculoskeletal Diseases
Date applied
12/02/2013
Date assigned
14/02/2013
Last edited
22/05/2013
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Rhea Zambellas

ORCID ID

Contact details

Windmill Road
Oxford
OX3 7LD
United Kingdom
rhea.zambellas@ndorms.ox.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00974493

Protocol/serial number

13780

Study information

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

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

Ethics approval

Oxford REC B, 8th January 2013, ref: 13/SC/0016

Study design

Multi-centre randomised open label study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

http://www.ndorms.ox.ac.uk/downloads/oviva.patientinfo.v1-2.pdf

Condition

Bone and joint infection

Intervention

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)

Intervention type

Drug

Phase

Not Applicable

Drug names

Antibiotics

Primary outcome measures

Treatment failure; Timepoint(s): Recurrence of infection within one year of randomisation

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/03/2013

Overall trial end date

28/02/2016

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

UK Sample Size: 1050

Participant 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.

Recruitment start date

01/03/2013

Recruitment end date

28/02/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Windmill Road
Oxford
OX3 7LD
United Kingdom

Sponsor information

Organisation

Oxford Radcliffe Hospitals NHS Trust (UK)

Sponsor details

Headley Way
Headington
Oxford
OX3 9DU
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.oxfordradcliffe.nhs.uk/home.aspx

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK) (11/36/29)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes