MRSA Decolonization in Complicated Carriage - Cluster Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 211
- 试验地点
- 1
- 主要终点
- success rate
研究概览
简要总结
Multicenter open-label cluster randomized controlled trial determining the superiority of doxycycline-rifampicin compared to trimethoprim-rifampicin for the decolonization treatment of complicated MRSA carriership.
详细描述
Rationale: MRSA decolonization has proven to prevent infection and reduce transmission. It has yet remained undecided which combination of anti-staphylococcal agents is most effective in the treatment of complicated MRSA carriage. A recent cohort study showed the highest success rate of decolonization in patients treated with doxycycline-rifampicin (86%) compared to the other antibiotic combinations (average 69%). However, because of the retrospective study design the validity of the results is limited. A randomized clinical study is necessary to determine if doxycycline-rifampicin is superior to other conventional treatment regimens. The Dutch guideline recommends both doxycycline-rifampicin and trimethoprim-rifampicin as first choice treatments for decolonization of complicated MRSA carriage. Therefore trimethoprim-rifampicin will be the comparator of this study.
Objective: To determine the superiority of doxycycline-rifampicin compared to trimethoprim-rifampicin for the decolonization treatment of complicated MRSA carriership.
Study design: Multicenter open-label cluster randomized controlled trial.
Study population: Adult (>18 years) patients with complicated MRSA carriership, treated at one of the participating outpatient clinics. Sample size 211 patients.
Intervention: Group A: doxycycline 200 mg q.d. - rifampicin 600mg b.i.d. versus Group B: trimethoprim 200mg b.i.d. - rifampicin 600mg b.i.d. All orally, total duration 7 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Complicated MRSA carriership. Complicated carriership is defined as having one of the following features: (i) the presence of MRSA located at another site than the nose, (ii) an active infection with MRSA, (iii) in vitro resistance for mupirocin, (iv) active skin lesions, (v) foreign material that connects an internal body site with the outside (e.g., urine catheter, external fixation material), (vi) previously failure of decolonization treatment.
- •In case of none of the previously mentioned features, this is considered uncomplicated carriership.
- •The ability to provide informed consent for the use of their data.
排除标准
- •- Presence of any iv-access, urinary catheters or drains (because of high risk of treatment failure)
- •Failure of previous decolonization attempt of complicated MRSA carriage
- •Allergy or other contra-indication to either doxycycline, rifampicin or trimethoprim (these patients will participate in the observational arm)
- •Previous participation in this study (every patient can only participate once)
- •Pregnancy
研究组 & 干预措施
A
doxycycline 200 mg q.d. - rifampicin 600mg b.i.d.
干预措施: doxycycline 200 mg q.d. - rifampicin 600mg b.i.d. (Drug)
B
trimethoprim 200mg b.i.d. - rifampicin 600mg b.i.d.
干预措施: trimethoprim 200mg b.i.d. - rifampicin 600mg b.i.d. (Drug)
结局指标
主要结局
success rate
时间窗: 3 consecutive negative cultures after treatment, with a minimum interval of 7 days.
success rate of MRSA decolonization
次要结局
- long term success rate(1 year)
研究者
acwestgeest
Principal investigator
Leiden University Medical Center