Comparison of the Pharmacokinetic and the Safety of Daptomycin Administered Subcutaneously Compared to the Intravenous Route : a Cross-over Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- daptomycin dosage after intravenous route
研究概览
简要总结
Background:
Multidrug-resistant bacteria are a major public health problem worldwide, notably due to excess mortality and an increase in the length of hospital stay. Antibiotics that can be used to treat these infections are limited. Daptomycin is one of the most widely used antibiotics for the treatment of infections with gram-positive bacteria, such as methicillin-resistant Staphylococcus aureus (MRSA). However, it is only administered intravenously (IV). It is therefore interesting to find new routes of administration in order to widen the possibilities of using daptomycin, especially in people who have difficulties with the venous approach.
Methods/design:
In a randomized, single blinded, crossover, noninferiority study in the CHU of Caen, the investigators aim to demonstrate the pharmacokinetic bioequivalence between the subcutaneous and the intravenous route of daptomycin in healthy volunteers. They will conclude the bioequivalence if the confidence interval of the area under the curve obtained is entirely within the interval [80% - 125%].
Discussion:
This clinical trial could, if bioequivalence is demonstrated, lead to the completion of a clinical trial in infected patients in order to assess the efficacy and safety of daptomycin by the subcutaneous route.
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
- Single (Participant)
盲法说明
Subcutaneous administration of daptomycin and placebo will be done blind to the participant. Given the yellow coloration of daptomycin, a masking of the pockets of daptomycin and NaCl will be carried out with a pocket cover and an opaque tube will be used for the administration
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteer from 18 to 65 years old
- •Subject determined in good health by a doctor
- •Signature of free and informed consent
- •Affiliated to the French healthcare insurance
- •Fluent in French
排除标准
- •Active bacterial or viral infection
- •Immunocompromised
- •Body mass index <20 or> 30 kg / m2
- •Kidney failure with glomerular filtration rate <90ml / min / m2 calculated according to the CKD-EPI method
- •Known or suspected liver disease
- •Pregnant or lactating woman
- •Guardianship or curators
- •Any situation that could interfere with the self / hetero assessment of pain (dementia, psychiatric disorders, for example)
- •Concomitant intake of myotoxic drugs (statins, fibrates, ciclosporin, for example)
- •Allergy or known side effects to daptomycin
- •Dermatological pathologies which may interfere with the subcutaneous injection (eczema, psoriasis, etc.)
- •Localized tattoo or piercing on the abdomen which may interfere with the subcutaneous injection or the evaluation of possible local effects of the injection
- •Parenteral exposure to daptomycin in the previous 30 days
- •The inclusion of the subject in another interventional research protocol (during the present study and in the 3 months before inclusion).
研究组 & 干预措施
Dapto SC-IV
First stage :
- Subcutaneous injection of daptomycin 10mg/kg
- Subcutaneous injection of placebo (physiological serum)
Second stage :
- Intravenous injection of daptomycin 10mg/kg
干预措施: Daptomycin (Drug)
Dapto IV-SC
First stage :
- Intravenous injection of daptomycin 10mg/kg
Second stage :
- Subcutaneous injection of daptomycin 10mg/kg
- Subcutaneous injection of placebo (physiological serum)
干预措施: Daptomycin (Drug)
结局指标
主要结局
daptomycin dosage after intravenous route
时间窗: 24 hours after injection
measurement of daptomycin blood concentration after intravenous route
daptomycin dosage after subcutaneous route
时间窗: 24 hours after injection
measurement of daptomycin blood concentration after subcutaneous route
daptomycin dosage after intravenous route
时间窗: before injection
measurement of daptomycin blood concentration after intravenous route
daptomycin dosage after intravenous route
时间窗: 30 minutes after injection
measurement of daptomycin blood concentration after intravenous route
daptomycin dosage after intravenous route
时间窗: 1 hours after injection
measurement of daptomycin blood concentration after intravenous route
daptomycin dosage after intravenous route
时间窗: 1,50 hours after injection
measurement of daptomycin blood concentration after intravenous route
daptomycin dosage after intravenous route
时间窗: 2 hours after injection
measurement of daptomycin blood concentration after intravenous route
daptomycin dosage after intravenous route
时间窗: 3 hours after injection
measurement of daptomycin blood concentration after intravenous route
daptomycin dosage after intravenous route
时间窗: 4 hours after injection
measurement of daptomycin blood concentration after intravenous route
daptomycin dosage after intravenous route
时间窗: 8 hours after injection
measurement of daptomycin blood concentration after intravenous route
daptomycin dosage after intravenous route
时间窗: 10 hours after injection
measurement of daptomycin blood concentration after intravenous route
daptomycin dosage after subcutaneous route
时间窗: before injection
measurement of daptomycin blood concentration after subcutaneous route
daptomycin dosage after subcutaneous route
时间窗: 30 minutes after injection
measurement of daptomycin blood concentration after subcutaneous route
daptomycin dosage after subcutaneous route
时间窗: 1 hours after injection
measurement of daptomycin blood concentration after subcutaneous route
daptomycin dosage after subcutaneous route
时间窗: 1.50 hours after injection
measurement of daptomycin blood concentration after subcutaneous route
daptomycin dosage after subcutaneous route
时间窗: 2 hours after injection
measurement of daptomycin blood concentration after subcutaneous route
daptomycin dosage after subcutaneous route
时间窗: 3 hours after injection
measurement of daptomycin blood concentration after subcutaneous route
daptomycin dosage after subcutaneous route
时间窗: 4 hours after injection
measurement of daptomycin blood concentration after subcutaneous route
daptomycin dosage after subcutaneous route
时间窗: 8 hours after injection
measurement of daptomycin blood concentration after subcutaneous route
daptomycin dosage after subcutaneous route
时间窗: 10 hours after injection
measurement of daptomycin blood concentration after subcutaneous route
次要结局
- Local adverse events(7 days after the infusion)
- Systemic adverse events(7 days after the infusion)
- Local adverse events(within the first 24hours after injection)
- Local adverse events(3 days after the infusion)
- Systemic adverse events(within the first 24hours after injection)
- Systemic adverse events(3 days after the infusion)