NCT00974493

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,054

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jun 2010

Longer than P75 for phase_4

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2009

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 10, 2009

Completed
9 months until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2017

Completed
3.3 years until next milestone

Results Posted

Study results publicly available

June 5, 2020

Completed
Last Updated

June 5, 2020

Status Verified

June 1, 2020

Enrollment Period

2.8 years

First QC Date

September 4, 2009

Results QC Date

February 24, 2020

Last Update Submit

June 3, 2020

Conditions

Bone InfectionJoint Infection

Keywords

oralintravenousantibioticsbonejointinfection

Outcome Measures

Primary Outcomes (1)

  • The Frequency of Definite Failure of Infection Treatment.

    Number of participants with definite failure of infection treatment defined by microbiological, histological and clinical criteria and assessed by an independent blinded endpoint committee

    1 year

Study Arms (2)

Oral antibiotics

ACTIVE COMPARATOR
Drug: Antibiotics

Intravenous antibiotics

ACTIVE COMPARATOR
Drug: Antibiotics

Interventions

AntibioticsDRUG

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.

Also known as: Individual antibiotics not specified by protocol
Intravenous antibioticsOral antibiotics

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Is willing and able to give informed consent for participation in the study. Has a bone and joint infection one of the following categories;
  • Native osteomyelitis.
  • Native joint septic arthritis.
  • Diabetic foot infection with osteomyelitis.
  • Prosthetic joint associated infection.
  • 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.

You may not qualify if:

  • Has Staph aureus bacteraemia.
  • Has suspected bacterial endocarditis.
  • Has suspected mediastinal infection.
  • Has suspected central nervous system infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Nuffield Orthopaedic Centre

Oxford, Oxfordshire, OX3 7LD, United Kingdom

Location

Oxford Radcliffe Hospitals Trust

Oxford, Oxfordshire, OX3 9DU, United Kingdom

Location

MeSH Terms

Conditions

Infections

Interventions

Anti-Bacterial Agents

Intervention Hierarchy (Ancestors)

Anti-Infective AgentsTherapeutic UsesPharmacologic ActionsChemical Actions and Uses

Results Point of Contact

Title
Matthew Scarborough
Organization
Oxford University Hospitals NHS Trust
matthew.scarborough@ouh.nhs.uk
07872436461

Study Officials

  • Philip Bejon, PhD

    Oxford Radcliffe Hospitals Trust

    PRINCIPAL INVESTIGATOR

  • Matthew Scarborough, MB BS

    Oxford University Hospitals

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Primary Investigator

Study Record Dates

First Submitted

September 4, 2009

First Posted

September 10, 2009

Study Start

June 1, 2010

Primary Completion

March 1, 2013

Study Completion

February 28, 2017

Last Updated

June 5, 2020

Results First Posted

June 5, 2020

Record last verified: 2020-06

Locations

GB(2)