Oral vs Intravenous Antibiotics (OVIVA) for Bone and Joint Infection

Plain English Summary

Background and study aims
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 in hospital for treatment, so outpatient antibiotic therapy (OPAT) programs have been established in many centres to deliver intravenous antibiotics safely and conveniently. Most patients referred to OPAT programs have bone and joint infections. However, there is no clear evidence that bone and joint infections really require long courses of intravenous antibiotics rather than oral antibiotics (tablets). We will compare the outcome of treatment with intravenous and oral antibiotic therapy for patients with bone and joint infection.

Who can participate?
Patients aged 18 or over with an infection in a bone or joint that needs treatment with a long course of antibiotics.

What does the study involve?
The choice of antibiotic is complex, and antibiotics that are suitable oral choices are often not suitable intravenous choices and vice versa. Participants will therefore be randomly allocated to an oral or intravenous ‘strategy’, rather than to individual antibiotics. Patients will be followed up carefully by the study staff for a year; clinical follow up beyond this point may still be required outside the context of the study. We will also look for differences between the two groups in terms of quality of life, side effects, complications, cost and adherence to prescribed antibiotics.

What are the possible benefits and risks of participating?
There are no direct benefits from taking part in the study other than in helping to identify the best treatment strategy for future patients. However, there are advantages and disadvantages of both intravenous and oral antibiotics. Patients allocated to the intravenous group are likely to be closely supervised by specialist nurses. However, many patients find intravenous therapy inconvenient. On the other hand, patients allocated to oral treatment may find the tablets easier and more convenient but they are less likely to be closely supervised by nurses and may therefore be at greater risk of missing doses. At the moment we do not know which antibiotic strategy (intravenous or oral) is most effective, or whether any difference in effectiveness might be balanced by a difference in side effects. If there is a difference, you might be allocated (by chance) to an antibiotic strategy that turns out at the end of the study either to have more side effects or to be less effective. The various antibiotics used to treat bone and joint infections all have different side effects, which the doctor looking after you will explain. In general, antibiotics tablets are more likely to cause nausea and vomiting than antibiotics given by injection. Both tablets and antibiotic injections may cause diarrhoea or a rash. The initial insertion of an intravenous line used for administering antibiotics by injection involves some discomfort but this is usually mild. Intravenous lines have a small risk of becoming infected themselves and very occasionally, they can cause irritation or blood clots in the vein. Under these circumstances, the line may have to be removed. It is important to remember that risks would be no different if you chose not to be in the trial because it is currently standard practice in your hospital to give antibiotics intravenously in the treatment of bone and joint infection.

Where is the study run from?
The Botnar Research Centre, University of Oxford (UK).

When is the study starting and how long is it expected to run for?
From March 2013 to February 2017.

Who is funding the study?
NIHR Health Technology Assessment Programme - HTA (UK).

Who is the main contact?
Rhea Zambellas
rhea.zambellas@ndorms.ox.ac.uk

Study website

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• England
• United Kingdom

Study participating centre

Sponsor information

Oxford Radcliffe Hospitals NHS Trust (UK)
Hospital/treatment centre

Headley Way
Headington
Oxford
OX3 9DU
England
United Kingdom

Website	http://www.oxfordradcliffe.nhs.uk/home.aspx
"ROR"	https://ror.org/03h2bh287

Funders

Funder type

Government

Results and Publications

Study outputs

Editorial Notes

05/08/2019: Publication reference and total final enrolment added.
11/02/2019: Publication reference added.
11/12/2018: No publications found, verifying study status with principal investigator.
23/12/2015: Publication reference added.