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: November 13, 2012
Last verified: November 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 1050
Study Start Date: June 2010
Estimated Study Completion Date: March 2013
Estimated 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00974493

Locations
United Kingdom
Oxford Radcliffe Hospitals Trust
Oxford, Oxfordshire, United Kingdom, OX3 9DU
Nuffield Orthopaedic Centre
Oxford, Oxfordshire, United Kingdom, OX3 7LD
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

No publications provided

Responsible Party: Philip Bejon, PI, Oxford University Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT00974493     History of Changes
Other Study ID Numbers: OVIVA
Study First Received: September 4, 2009
Last Updated: November 13, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

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

Additional relevant MeSH terms:
Osteomyelitis
Arthritis, Infectious
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Arthritis
Joint Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on April 23, 2014