Evaluation of Amoxicillin Diffusion in Breast Milk According to a Population Pharmacokinetic Approach (CONCEPTION-AMOX) — CONCEPTION  

Breast Feeding, Exclusive Clinical Trial

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

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

This study will complement the clinical data on amoxicillin in breastfed new-borns considering that current knowledge in terms of authorized drugs use during breastfeeding is not sufficient to guarantee the child absence of exposure, even minimal. As a consequence, this lack of certainties leads to premature discontinuation of breastfeeding, well known to be beneficial for the breastfed new-borns. Amoxicillin, prescribed alone or with clavulanic acid at 2 to 3g per day for 7 days, including in lactating women, is mainly used to treat β-hemolytic strep throat, infections of the genitourinary tract as well as ear, nose and throat infections. ;

Related Conditions & MeSH terms

• Breast Feeding, Exclusive

• NCT number: NCT05051787
• Study type: Interventional
• Source: University Hospital, Toulouse
• Status: Completed
• Phase: Phase 4
• Start date: June 23, 2022
• Completion date: July 12, 2023