Bone and joint infection including
Conditions
Interventions
Pharmaceutical Form:
Sponsors
Oxford Radcliffe Hospitals Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: We will compare the frequency of treatment failure with oral versus intravenous antibiotic treatment in two centres supported by a single clinical infection service. This will be needed to exclude a very marked worsening of outcome in patients on oral antibiotics. These data will be needed to justify a larger multi-centre study.;Secondary Objective: To measure the nature, frequency and intensity of adverse events resulting from oral versus intravenous antibiotics. To identify the development of antibiotic resistance while on therapy or during the follow-up period.;Primary end point(s): The primary endpoint will be definite failure of infection treatment, where definite failure is indicated by one or more of the following; 1. Significant positive culture results from invasive specimens taken from the infected site, where cultures where taken for evidence of worsening infection (i.e. not taken as a matter of routine at planned surgery). 2. A positive culture result from a blood specimen taken in association with clinical signs of recurrent infection at the primary site of treatment, and where there is no other likely source of the positive blood culture (e.g., line infection, pneumonia). 3. An operative appearance of the infected site diagnostic of active infection at the time of unplanned surgery (e.g., frank pus or necrotic tissue) 4. A sinus tract at the infected site =3 weeks after surgical intervention. | — |
Countries
United Kingdom
Outcome results
None listed