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

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ClinicalTrials.gov Identifier: NCT00974493
Recruitment Status : Completed
First Posted : September 10, 2009
Results First Posted : June 5, 2020
Last Update Posted : June 5, 2020
Sponsor:
Information provided by (Responsible Party):
Matthew Scarborough, Oxford University Hospitals NHS Trust

Tracking Information
First Submitted Date  ICMJE September 4, 2009
First Posted Date  ICMJE September 10, 2009
Results First Submitted Date  ICMJE February 24, 2020
Results First Posted Date  ICMJE June 5, 2020
Last Update Posted Date June 5, 2020
Study Start Date  ICMJE June 2010
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2020)
The Frequency of Definite Failure of Infection Treatment. [ Time Frame: 1 year ]
Number of participants with definite failure of infection treatment defined by microbiological, histological and clinical criteria and assessed by an independent blinded endpoint committee
Original Primary Outcome Measures  ICMJE
 (submitted: September 9, 2009)
The frequency of definite failure of infection treatment, defined by objective criteria. [ Time Frame: 1 year ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2009)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oral Versus Intravenous Antibiotics for Bone and Joint Infections (OVIVA B&J)
Official Title  ICMJE Randomized Open Label Study of Oral Versus Intravenous Antibiotic Treatment for Bone and Joint Infections Requiring Prolonged Antibiotic Treatment: Multi-centre Study
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Bone Infection
  • Joint Infection
Intervention  ICMJE 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
Study Arms  ICMJE
  • Active Comparator: Oral antibiotics
    Intervention: Drug: Antibiotics
  • Active Comparator: Intravenous antibiotics
    Intervention: Drug: Antibiotics
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 3, 2020)
1054
Original Estimated Enrollment  ICMJE
 (submitted: September 9, 2009)
200
Actual Study Completion Date  ICMJE February 28, 2017
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00974493
Other Study ID Numbers  ICMJE OVIVA
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Matthew Scarborough, Oxford University Hospitals NHS Trust
Study Sponsor  ICMJE Oxford University Hospitals NHS Trust
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Philip Bejon, PhD Oxford Radcliffe Hospitals Trust
Principal Investigator: Matthew Scarborough, MB BS Oxford University Hospitals
PRS Account Oxford University Hospitals NHS Trust
Verification Date June 2020

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