Randomized open label study of oral versus intravenous antibiotic treatment for bone and joint infections requiring prolonged antibiotic treatment: Preliminary study in a single centre. - Oral versus intravenous antibiotics for bone and joint infectio

• Conditions: Bone and joint infection including; oOsteomyelitis. oSeptic arthritis.oProsthetic joint associated infectionoOrthopaedic device associated infectionoDiscitis/ epidural abscess

• Registration Number: EUCTR2009-015744-42-GB
• Lead Sponsor: Oxford Radcliffe Hospitals Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09-11
• Last Update Posted: 17 June 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

•Is willing and able to give informed consent for participation in the study.
•Has a bone and joint infection* in one of the following categories;
1.Native osteomyelitis (i.e., bone infection without metalwork) where a prolonged (i.e., 6 week) course of antibiotics is indicated (i.e., excluding limited superficial disease, or patients where curative amputations or excisions of all infected bone have been carried out).
2.Native joint septic arthritis treated by excision arthoplasty, with or without intended 2-stage revision.
3.Diabetic foot infection with proven or presumptive osteomyelitis where a prolonged (i.e. 6 week) course of antibiotics is indicated (i.e., excluding limited superficial disease or patients where curative excision of all infected bone has been carried out).
4.Prosthetic joint associated infection treated by debridement and retention
5.Orthopaedic device associated infection treated by debridement and retention
6.Prosthetic joint associated infection where a 2 stage revision is planned, randomizing the patient after the 1st stage (i.e., after excision of the infected prosthesis).
7.Prosthetic joint associated infection treated by 1 stage revision
8.Removal of orthopaedic device or bone graft for infection (excluding limited superficial disease requiring short courses of antibiotics).
9. 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).
•Has a life expectancy > 1 year.
•Is clinically stable in the opinion of the study clinicians, has no further interventions to treat acute infection required or planned.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Has Staph aureus bacteraemia found on blood cultures taken for clinical indications. (No study-required blood cultures will be taken). Patients with Staph aureus bacteraemia often require longer courses of intravenous antibiotics, and may be the subject of a separate randomized trial.
•Has suspected bacterial endocarditis, based on clinical, microbiological or imaging studies. (No study-required echocardiograms will be requested). Patients with endocarditis are considered to need longer courses of intravenous antibiotics.
•Has suspected mediastinial infection
•Has suspected central nervous system infection
•Is unlikely to comply with trial requirements in the opinion of the investigator.
•Has an infection for which there is no suitable antibiotic choices to permit randomization between the two arms of the trial
•Has a non-bacterial (i.e., mycobacterial, fungal, parasitic or viral) infection based on clinical, histological or microbiological findings at site of infection.
•Previously enrolled in the trial.
•Is receiving an investigational medical product as part of another clinical trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified