Condition category
Musculoskeletal Diseases
Date applied
Date assigned
Last edited
Prospectively registered
Overall trial status
Recruitment status

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Ms Rhea Zambellas


Contact details

Windmill Road
United Kingdom

Additional identifiers

EudraCT number number


Protocol/serial number


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



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:

More details can be found at:

Ethics approval

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

Study design

Multi-centre randomised open label study

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet


Bone and joint infection


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



Not Applicable

Drug names


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


Overall trial end date


Reason abandoned


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


Age group




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


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Windmill Road
United Kingdom

Sponsor information


Oxford Radcliffe Hospitals NHS Trust (UK)

Sponsor details

Headley Way
United Kingdom

Sponsor type

Hospital/treatment centre



Funder type


Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype


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