Evaluation of Amoxicillin Diffusion in Breast Milk According to a Population Pharmacokinetic Approach.

RC31/21/0217

Based on plasma and milk concentrations, a PopPK model will be performed (i) to document the average and individual exposure to amoxicillin in milk, (ii) to identify the factors explaining the inter-individual pharmacokinetic variability and (iii) to determine the daily dose ingested by the infant and its variability for different dosage regimens applied to the mother. The secondary objectives are to monitor (i) predefined adverse reactions in infants and (ii) the impact on milk production.

2022-06-23

2023-07-12

2023-07-12

Completed

Early phase I

25

Inclusion Criteria: * Mothers over 18 years, treated by amoxicillin for at least 2 days who breastfeed their child, - Participation requires that breastfeeding is already well established (i.e., at least 2 weeks after giving birth in order to sample mature milk) and that the infant is over 4 weeks old, * Affiliation to the social security scheme or equivalent, * Ability to understand and willingness to sign a written Informed Consent document. Exclusion Criteria: * Mothers under 18 years old, * Infants born prematurely (i.e., gestational age under 34 weeks) or requiring appropriate medical supervision or support from a team of social workers, * Mothers who gave birth to twins, * Inability to communicate due to language problems for the mother, * Patient subject to a legal protection order (curatorship or tutorship).

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2023-08-23