CTIS2022-501620-26-00招募中1 期
Rifampicin Combination Therapy versus Targeted Antimicrobial Monotherapy in the Oral Antimicrobial Treatment Phase of Staphylococcal Prosthetic Joint Infection - 2022-501620-26-00
eiden University Medical Center0 个研究点目标入组 316 人开始时间: 2022年11月29日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 316
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •All adult patients, aged 18 years or older AND, Diagnosed and hospitalized with hip- or knee prosthetic joint infection caused by Staphylococcus spp AND, Treated with DAIR: Debridement, Antibiotics and Implant Retention
排除标准
- •(i)a contra-indication for rifampicin (e.g. a resistant strain or proven allergic reaction or difficult drug-drug-interactions) (ii)complicated S. aureus bacteremia or concurrent endocarditis requiring long-term iv antibiotic treatment > 2 weeks (iii)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) (iv)treatment failure before the start of oral therapy, (v)an unsatisfactory response to initial treatment leading to continuation of intravenous therapy beyond day 21, (vi)patients with an expected life expectancy <12 months, (vii)patients with a tumor prosthesis (viii)patients receiving chemotherapy for active malignancy in the next 12 months (ix)patients who are scheduled in advance for chronic suppressive antibiotic therapy after the initial 12 weeks of antibiotic treatment (x)The patient is unlikely to comply with trial requirements following randomization in the opinion of the investigator (xi)Pregnancy (xii)Patients who are not able to read or communicate in Dutch or English will be excluded from participating in this study., (x)The patient is unlikely to comply with trial requirements following randomization in the opinion of the investigator, (xi)Pregnancy, (xii)Patients who are not able to read or communicate in Dutch or English will be excluded from participating in this study, (iii)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), (ii)complicated S. aureus bacteremia or concurrent endocarditis requiring long-term iv antibiotic treatment > 2 weeks, (iv)treatment failure before the start of oral therapy, (v)an unsatisfactory response to initial treatment leading to continuation of intravenous therapy beyond day 21, (vi)patients with an expected life expectancy <12 months, (vii)patients with a tumor prosthesis, (viii)patients receiving chemotherapy for active malignancy in the next 12 months, (ix)patients who are scheduled in advance for chronic suppressive antibiotic therapy after the initial 12 weeks of antibiotic treatment
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