Oral Versus Intravenous Antibiotics for Bone and Joint Infections (OVIVA B&J)

Joint Infection Clinical Trial

— OVIVA  

Official title:

Randomized Open Label Study of Oral Versus Intravenous Antibiotic Treatment for Bone and Joint Infections Requiring Prolonged Antibiotic Treatment: Multi-centre Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00974493
• Other study ID #: OVIVA
• Status: Completed
• Phase: Phase 4
• Start date: June 2010
• Est. completion date: February 28, 2017

Study information

• Verified date: June 2020
• Source: Oxford University Hospitals NHS Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1054
• Est. completion date: February 28, 2017
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Is willing and able to give informed consent for participation in the study. Has a bone and joint infection one of the following categories;

1. Native osteomyelitis.

2. Native joint septic arthritis.

3. Diabetic foot infection with osteomyelitis.

4. Prosthetic joint associated infection.

5. Discitis/ spinal osteomyelitis/ epidural abscess

• 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.

Exclusion Criteria:

• Has Staph aureus bacteraemia.

• Has suspected bacterial endocarditis.

• Has suspected mediastinal infection.

• Has suspected central nervous system infection.

Related Conditions & MeSH terms

• Arthritis, Infectious
• Bone Infection
• Communicable Diseases
• Infection
• Joint Infection

Intervention

Drug:
• Antibiotics
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.

Locations

Country	Name	City	State
United Kingdom	Nuffield Orthopaedic Centre	Oxford	Oxfordshire
United Kingdom	Oxford Radcliffe Hospitals Trust	Oxford	Oxfordshire

Sponsors (1)

Lead Sponsor	Collaborator
Oxford University Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 year