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

• 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: Oxford University Hospitals NHS Trust
• Information provided by (Responsible Party): Matthew Scarborough, Oxford University Hospitals NHS Trust

Tracking Information

• First Submitted Date: September 4, 2009
• First Posted Date: September 10, 2009
• Results First Submitted Date: February 24, 2020
• Results First Posted Date: June 5, 2020
• Last Update Posted Date: June 5, 2020
• Study Start Date: June 2010
• Actual Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (submitted: September 9, 2009): The frequency of definite failure of infection treatment, defined by objective criteria. [ Time Frame: 1 year ]
• Current Secondary Outcome Measures: Not Provided

Original Secondary Outcome Measures (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: Oral Versus Intravenous Antibiotics for Bone and Joint Infections (OVIVA B&J)
• Official Title: 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: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Bone Infection
• Joint Infection

Intervention

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

• Active Comparator: Oral antibiotics
  Intervention: Drug: Antibiotics
• Active Comparator: Intravenous antibiotics
  Intervention: Drug: Antibiotics

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 3, 2020): 1054
• Original Estimated Enrollment (submitted: September 9, 2009): 200
• Actual Study Completion Date: February 28, 2017
• Actual Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United Kingdom

Administrative Information

• NCT Number: NCT00974493
• Other Study ID Numbers: OVIVA
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Matthew Scarborough, Oxford University Hospitals NHS Trust
• Study Sponsor: Oxford University Hospitals NHS Trust
• Collaborators: Not Provided

Investigators

• 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