NCT05051787

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

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: University Hospital, Toulouse · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Breast Feeding, Exclusive

Interventions

Type	Name	Description
BIOLOGICAL	Blood and milk samples	2 types of samples will be taken over the same time slots in breastfeeding mothers treated with amoxicillin for at least 2 days: * 3 breast milk collections of about 20 ml each made using an electric breast pump provided to the participant. * 3 blood samples of approximately 5 ml each.

Timeline

• Start date: 2022-06-23
• Primary completion: 2023-07-12
• Completion: 2023-07-12
• First posted: 2021-09-21
• Last updated: 2023-08-23

Locations

2 sites across 1 country: France