Clinical trial NCT00974493: Oral Versus Intravenous Antibiotics for Bone and Joint Infections (OVIVA B&J)
Official title: Randomized Open Label Study of Oral Versus Intravenous Antibiotic Treatment for Bone and Joint Infections Requiring Prolonged Antibiotic Treatment: Multi-centre Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bone Infection
Joint Infection
Keywords: oral
intravenous
antibiotics
bone
joint
infection
Lead sponsor: Oxford University Hospitals NHS Trust
Sponsor class: OTHER
First posted: 2009-09-10
Enrollment: 1054
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Frequency of Definite Failure of Infection Treatment.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Nuffield Orthopaedic Centre
state: Oxfordshire
city: Oxford
country: United Kingdom
facility: Oxford Radcliffe Hospitals Trust
state: Oxfordshire
Study officials:
affiliation: Oxford Radcliffe Hospitals Trust
name: Philip Bejon, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oxford University Hospitals
name: Matthew Scarborough, MB BS
role: PRINCIPAL_INVESTIGATOR
References: