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

NCT00974493 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1054

Last updated 2020-06-05

Study results available
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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.

Conditions

  • Bone Infection
  • Joint Infection

Interventions

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.

Sponsors & Collaborators

  • Oxford University Hospitals NHS Trust

    lead OTHER

Principal Investigators

  • Philip Bejon, PhD · Oxford Radcliffe Hospitals Trust

  • Matthew Scarborough, MB BS · Oxford University Hospitals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-06-30
Primary Completion
2013-03-31
Completion
2017-02-28

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00974493 on ClinicalTrials.gov