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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00974493
First Posted: September 10, 2009
Last Update Posted: November 6, 2017
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.
Information provided by (Responsible Party):
Oxford University Hospitals NHS Trust
  Purpose
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.

Condition Intervention Phase
Bone Infection Joint Infection Drug: Antibiotics Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Open Label Study of Oral Versus Intravenous Antibiotic Treatment for Bone and Joint Infections Requiring Prolonged Antibiotic Treatment: Multi-centre Study

Resource links provided by NLM:


Further study details as provided by Oxford University Hospitals NHS Trust:

Primary Outcome Measures:
  • The frequency of definite failure of infection treatment, defined by objective criteria. [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 1050
Study Start Date: June 2010
Study Completion Date: February 28, 2017
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Oral antibiotics 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: Intravenous antibiotics 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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00974493


Locations
United Kingdom
Nuffield Orthopaedic Centre
Oxford, Oxfordshire, United Kingdom, OX3 7LD
Oxford Radcliffe Hospitals Trust
Oxford, Oxfordshire, United Kingdom, OX3 9DU
Sponsors and Collaborators
Oxford University Hospitals NHS Trust
Investigators
Principal Investigator: Philip Bejon, PhD Oxford Radcliffe Hospitals Trust
Principal Investigator: Matthew Scarborough, MB BS Oxford University Hospitals
  More Information

Responsible Party: Oxford University Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT00974493     History of Changes
Other Study ID Numbers: OVIVA
First Submitted: September 4, 2009
First Posted: September 10, 2009
Last Update Posted: November 6, 2017
Last Verified: October 2014

Keywords provided by Oxford University Hospitals NHS Trust:
oral
intravenous
antibiotics
bone
joint
infection

Additional relevant MeSH terms:
Infection
Communicable Diseases
Arthritis, Infectious
Arthritis
Joint Diseases
Musculoskeletal Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents