Pharmacology of Mupirocin in Nasal Application in Healthy Volunteers: Monocentric Study
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- plasma concentrations of mupirocin
研究概览
简要总结
Mupirocin is an old antibiotic used topically since the 1970s. Initially used in the treatment of skin infections for its antistaphylococcal action, it is now part of the decolonization strategy for Staphylococcus aureus (SA) carriage, in association with chlorhexidine. This decolonization strategy has been recommended in France for preoperative cardiac surgery in nasal SA carriers since 2013 by the French Hospital Hygiene Society, and recommended for cardiac and orthopedic surgery in SA carriers by the World Health Organization (WHO) since 2016. This strategy includes nasal decolonization using mupirocin ointment nasally (2 to 3 applications/day), a daily shower with chlorhexidine soap and + /- mouthwashes all over 5 days, often pre-operatively.
As a result, mupirocin is now widely used throughout the world, all the more so as, for reasons of ease of organization, many centers use this decolonization procedure universally (i.e. without prior screening for Staphylococcus aureus carriage), thus further increasing the use of this molecule.
Mupirocin administration methods are very vague, ranging from 2 to 3 applications per day and the application of "a match head", i.e. 50 mg, to 500 mg per nostril.
Mupirocin is bacteriostatic at low doses, becoming bactericidal at higher concentrations; low concentrations could favor the selection of resistance, so using the most effective dosage seems essential. This lack of precision in administration is linked to an almost complete ignorance of the pharmacokinetics of mupirocin and its metabolite (monic acid) after nasal application.
It therefore seems essential to conduct a pharmacokinetic study of this molecule, in order to eventually offer patients the regimen with the administration methods offering the best characteristics in terms of dosage and efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Other
- 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
- 是
入选标准
- •Subject affiliated or entitled to a social security plan
- •Subject having signed the consent to participate in the study
排除标准
- •Pregnancy in progress
- •Acute or chronic rhinorrhea
- •Allergy to mupirocin calcium or excipients
- •Any medication taken during the week preceding the beginning of the study
- •Notable medical history (cardiovascular, pulmonary, neurological pathology, etc.)
研究组 & 干预措施
Single dose part : 50mg mupirocin
- Single dose part = single dose of 50 mg mupirocin in each nostril
干预措施: Mupirocin (50 mg) (Drug)
Single dose part : 50mg mupirocin
- Single dose part = single dose of 50 mg mupirocin in each nostril
干预措施: blood samples after Single dose part (Biological)
Single dose part : 50mg mupirocin
- Single dose part = single dose of 50 mg mupirocin in each nostril
干预措施: nasal swab after Single dose part (Diagnostic Test)
Single dose part : 50mg mupirocin
- Single dose part = single dose of 50 mg mupirocin in each nostril
干预措施: Collection of urine after Single dose part (Other)
Single dose part : 500mg mupirocin
Single dose part = single dose of 500 mg mupirocin in each nostril
干预措施: Mupirocin (500 mg) (Drug)
Single dose part : 500mg mupirocin
Single dose part = single dose of 500 mg mupirocin in each nostril
干预措施: blood samples after Single dose part (Biological)
Single dose part : 500mg mupirocin
Single dose part = single dose of 500 mg mupirocin in each nostril
干预措施: nasal swab after Single dose part (Diagnostic Test)
Single dose part : 500mg mupirocin
Single dose part = single dose of 500 mg mupirocin in each nostril
干预措施: Collection of urine after Single dose part (Other)
Repeated dose part: Group 1 - 50 mg of mupirocin twice a day
50 mg of mupirocin in each nostril twice a day (morning and evening) for 5 days
干预措施: Mupirocin (50 mg) (Drug)
Repeated dose part: Group 1 - 50 mg of mupirocin twice a day
50 mg of mupirocin in each nostril twice a day (morning and evening) for 5 days
干预措施: nasal swab during Repeated dose part (Diagnostic Test)
Repeated dose part: Group 1 - 50 mg of mupirocin twice a day
50 mg of mupirocin in each nostril twice a day (morning and evening) for 5 days
干预措施: Collection of urine during Repeated dose part (Other)
Repeated dose part: Group 2 50 mg of mupirocin 3 times a day
50 mg of mupirocin in each nostril 3 times a day (morning, noon and evening) for 5 days
干预措施: nasal swab after Repeated dose part (Other)
Repeated dose part: Group 1 - 50 mg of mupirocin twice a day
50 mg of mupirocin in each nostril twice a day (morning and evening) for 5 days
干预措施: nasal swab after Repeated dose part (Other)
Repeated dose part: Group 2 50 mg of mupirocin 3 times a day
50 mg of mupirocin in each nostril 3 times a day (morning, noon and evening) for 5 days
干预措施: Mupirocin (50 mg) (Drug)
Repeated dose part: Group 2 50 mg of mupirocin 3 times a day
50 mg of mupirocin in each nostril 3 times a day (morning, noon and evening) for 5 days
干预措施: nasal swab during Repeated dose part (Diagnostic Test)
Repeated dose part: Group 2 50 mg of mupirocin 3 times a day
50 mg of mupirocin in each nostril 3 times a day (morning, noon and evening) for 5 days
干预措施: Collection of urine during Repeated dose part (Other)
Repeated dose part: Group 3 500 mg of mupirocin twice a day
500 mg of mupirocin in each nostril twice a day (morning and evening) for 5 days
干预措施: Mupirocin (500 mg) (Drug)
Repeated dose part: Group 3 500 mg of mupirocin twice a day
500 mg of mupirocin in each nostril twice a day (morning and evening) for 5 days
干预措施: nasal swab during Repeated dose part (Diagnostic Test)
Repeated dose part: Group 3 500 mg of mupirocin twice a day
500 mg of mupirocin in each nostril twice a day (morning and evening) for 5 days
干预措施: Collection of urine during Repeated dose part (Other)
Repeated dose part: Group 3 500 mg of mupirocin twice a day
500 mg of mupirocin in each nostril twice a day (morning and evening) for 5 days
干预措施: nasal swab after Repeated dose part (Other)
Repeated dose part: Group 4 500 mg of mupirocin 3 times a day
500 mg of mupirocin in each nostril 3 times a day (morning non and evening) for 5 days
干预措施: Mupirocin (500 mg) (Drug)
Repeated dose part: Group 4 500 mg of mupirocin 3 times a day
500 mg of mupirocin in each nostril 3 times a day (morning non and evening) for 5 days
干预措施: nasal swab during Repeated dose part (Diagnostic Test)
Repeated dose part: Group 4 500 mg of mupirocin 3 times a day
500 mg of mupirocin in each nostril 3 times a day (morning non and evening) for 5 days
干预措施: Collection of urine during Repeated dose part (Other)
Repeated dose part: Group 4 500 mg of mupirocin 3 times a day
500 mg of mupirocin in each nostril 3 times a day (morning non and evening) for 5 days
干预措施: nasal swab after Repeated dose part (Other)
结局指标
主要结局
plasma concentrations of mupirocin
时间窗: 2 hours after mupirocin application (Single dose part)
mupirocin pharmacokinetics
intranasal concentrations of mupirocin
时间窗: 12 hours after mupirocin application (Single dose part)
mupirocin pharmacokinetics
次要结局
- urinary concentrations of monic acid(Days: 5 after mupirocin application (Repeated dose part))
- presence of Staphylococcus aureus(Days: 90 after mupirocin application (Repeated dose part))