ISRCTN91566927已完成未知
Randomised open-label study of oral versus intravenous antibiotic treatment for bone and joint infections requiring prolonged antibiotic treatment: multi-centre study
Oxford Radcliffe Hospitals NHS Trust (UK)0 个研究点目标入组 1,054 人开始时间: 2013年2月14日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 1,054
研究概览
简要总结
- 2015 protocol in http://www.ncbi.nlm.nih.gov/pubmed/26690812 2. 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/30699315 3. 2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31373271 (added 05/08/2019)
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. A clinical syndrome comprising any of the following
- •1.1. Localized pain OR
- •1.2. Localized inflammation OR
- •1.3. Temperature >38.0ºC OR
- •1.4. A discharging wound AND
- •2. Willing and able to give informed consent
- •3. Male and female aged 18 years or above
- •4. The patient has received 7 days or less of intravenous therapy after an appropriate surgical intervention to treat bone or joint infection (regardless of pre-surgical antibiotics) or, if no surgical intervention is required, the patient has received 7 days or less of intravenous therapy after the start of the relevant clinical episode.
- •5. Has a life expectancy > 1 year
- •6. Has a bone and joint infection in one of the following categories
- •6.1. Native osteomyelitis (i.e., bone infection without metal implants such as artificial joints) affecting limb bone, skull, foot or other site OR 6.2. Native joint infection treated by surgical excision OR
- •6.3. Prosthetic joint infection treated by debridement and retention of the prosthesis, by one stage exchange of the prosthesis or by excision of the prosthetic joint (with or without planned re-implantation) OR
- •6.4. Orthopaedic device or bone-graft infection treated by debridement and retention, or by debridement and removal OR
- •6.5. Spinal infection
排除标准
- •1. Staphylococcus aureus bacteraemia (blood stream infection) on presentation or within the last 1 month
- •2. Bacterial endocarditis (heart valve infection) on presentation or within the last month (NB there are no study mandated investigations. Participants are not required to have echocardiograms, blood cultures, or any other investigations to exclude endocarditis in the absence of a clinical indication)
- •3. Any other concomitant infection which, in the opinion of the clinician responsible for the patient, required a prolonged intravenous course of antibiotics (e.g. central nervous system infection)
- •4. Mild osteomyelitis, defined as osteomyelitis which, in the opinion of the clinical investigator, would not usually require a 6 week course of intravenous antibiotics
- •5. An infection for which there are no suitable antibiotic choices to permit randomization between the two arms of the trial (for instance, where organisms are only sensitive to intravenous antibiotics, which occurred in <5% of patients during recruitment for our pilot study)
- •6. Previous enrolment in the trial
- •7. Septic shock or systemic features requiring intravenous antibiotics in the opinion of the treating clinician (the patient may be re-evaluated if these features resolve)
- •8. The patient is unlikely to comply with trial requirements following randomization (including specific requirement for PO or IV course) in the opinion of the investigator
- •9. There is laboratory evidence of mycobacterial (e.g. tuberculosis), fungal, parasitic or viral etiology
- •10. The patient is receiving an investigational medical product as part of another clinical trial.
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