Evaluation of Amoxicillin diffusion in breast milk according to a population pharmacokinetic approach. - CONCEPTION-AMOX

CHU TOULOUSE0 个研究点目标入组 25 人开始时间: 2021年7月2日最近更新: 2023年10月3日

适应症

试验速览

暂无简介。

•-Mothers over 18, treated with Amoxicillin for at least 2 days, breastfeeding their child and living in an area covered by the authorization of one of the ethics committees concerned by this multicenter study will be eligible for the study,
•-Participation requires that breastfeeding has been started for at least 2 weeks after childbirth and that the infant is more than 4 weeks old,
•-Affiliation to the social security scheme or equivalent,
•-Ability to understand and willingness to sign a written informed consent document for withdrawal of plasma and milk.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 25
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•-Mothers under 18 years old,
•-Infants born prematurely (i.e. gestational age of less than 34 weeks) or requiring appropriate medical supervision or the support of a team of social workers,
•-Mothers who have given birth to twins,
•-Inability to communicate with mother due to language problems,
•-Patient subject to a legal protection order (curatorship or tutorship)

发起方

CHU TOULOUSE