2024-516377-69-01招募中4 期
A randomized placebo-controlled double-blinded trial of the treatment of MRSA throat carriage with either standard decolonization therapy or standard decolonization therapy combined with oral clindamycin
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- MRSA negative swabs at 1 months
研究概览
简要总结
The main objective of this RCT is to investigate whether adding peroral clindamycin to the standard decolonization treatment with mupirocin nasal ointment and chlorhexidin body wash significantly improves the treatment success rate of MRSA throat carriers.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •MRSA carriage in the throat
- •Has completed one standard topical decolonization treatment
排除标准
- •Pregnant or lactating woman
- •Followed by specialist due to liver disease
- •Severe overweight (BMI > 35) or weight < 50 kg
- •Indwelling percutaneous permanent devices such as intravenous catheters or urinary tract catheters
- •Daily contact with pigs or minks (decolonization therapy is generally not offered, according to The National Board of Health)
- •Nursing home resident or health care worker (they have a more frequent control swab regime)
- •Not being capable of completing another treatment successfully
- •MRSA positive household members younger than 2 years (MRSA positive children below 2 years of age and their household members are generally not offered decolonization treatment according to The National Board of Health)
- •MRSA positive household members, where it is judged that further decolonization attempts are not indicated
- •Sexually active women in the reproductive age that do not use approved contraceptives
- •Cannot read or speak Danish or English
- •Skin infection or other active infections
- •Activity in skin diseases such as eczema or psoriasis
- •MRSA isolate resistant to clindamycin (defined by inhibition zone size < 22 mm using disk diffusion methodology) or resistant to mupirocin
- •Allergy to clindamycin, chlorhexidine or mupirocin
- •Taking medications that interact with clindamycin according to the medicine information leaflet.
- •MRSA active antibiotic treatment within 7 days before inclusion in the study or during study period
结局指标
主要结局
MRSA negative swabs at 1 months
MRSA negative swabs at 1 months
次要结局
- MRSA negative swabs after 6 months
研究者
Mette Damkjær Bartels
Scientific
Hvidovre Hospital
研究点 (2)
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