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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00974493
Recruitment Status : Completed
First Posted : September 10, 2009
Last Update Posted : November 6, 2017
Information provided by (Responsible Party):
Oxford University Hospitals NHS Trust

September 4, 2009
September 10, 2009
November 6, 2017
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 ]
Same as current
Complete list of historical versions of study NCT00974493 on Archive Site
  • Possible failure of infection treatment (specified in detail in the protocol). [ Time Frame: 1 year ]
  • Frequency and severity of adverse events [ Time Frame: 1 year ]
  • Possible failure of infection treatment (specified in detail in the protocol). [ Time Frame: 1 year ]
  • Frequency and severity of adverse events [ Time Frame: 6 weeks ]
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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.

Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
February 28, 2017
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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United Kingdom
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Oxford University Hospitals NHS Trust
Oxford University Hospitals NHS Trust
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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