Evaluation of Amoxicillin diffusion in breast milk.

Phase 1

• Conditions: Therapeutic area: Body processes [G] - Biological Phenomena [G16]; Breastfeeding

• Registration Number: EUCTR2021-002247-30-FR
• Lead Sponsor: CHU TOULOUSE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-02
• Last Update Posted: 3 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 25

Inclusion Criteria

-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

Exclusion Criteria

-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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified