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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Philip Bejon, Oxford University Hospitals NHS Trust
ClinicalTrials.gov Identifier:
NCT00974493
First received: September 4, 2009
Last updated: October 15, 2014
Last verified: October 2014

September 4, 2009
October 15, 2014
June 2010
March 2013   (final data collection date for primary outcome measure)
The frequency of definite failure of infection treatment, defined by objective criteria. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00974493 on ClinicalTrials.gov Archive Site
  • Possible failure of infection treatment (specified in detail in the protocol). [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Frequency and severity of adverse events [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Possible failure of infection treatment (specified in detail in the protocol). [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Frequency and severity of adverse events [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Oral Versus Intravenous Antibiotics for Bone and Joint Infections (OVIVA B&J)
Randomized Open Label Study of Oral Versus Intravenous Antibiotic Treatment for Bone and Joint Infections Requiring Prolonged Antibiotic Treatment: Multi-centre Study

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Bone Infection
  • Joint Infection
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.

Other Name: Individual antibiotics not specified by protocol
  • Active Comparator: Oral antibiotics
    Intervention: Drug: Antibiotics
  • Active Comparator: Intravenous antibiotics
    Intervention: Drug: Antibiotics
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
1050
November 2016
March 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT00974493
OVIVA
Yes
Philip Bejon, Oxford University Hospitals NHS Trust
Oxford University Hospitals NHS Trust
Not Provided
Principal Investigator: Philip Bejon, PhD Oxford Radcliffe Hospitals Trust
Principal Investigator: Matthew Scarborough, MB BS Oxford University Hospitals
Oxford University Hospitals NHS Trust
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP