EUCTR2009-015744-42-GB进行中（未招募）不适用
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 infection
Oxford Radcliffe Hospitals Trust0 个研究点目标入组 200 人开始时间: 2009年9月11日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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.
研究者
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