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

Phase 4

Completed

• Conditions: Breast Feeding, Exclusive
• Interventions: Biological: Blood and milk samples

• Registration Number: NCT05051787
• Lead Sponsor: University Hospital, Toulouse

Brief 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.

Study Timeline

• Study First Submitted: 2021-07-02
• Study First Submitted QC: 2021-09-09
• Study First Posted: 2021-09-21
• Study Start: 2022-06-23
• Primary Completion: 2023-07-12
• Study Completion: 2023-07-12
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-22
• Last Update Posted: 2023-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Breastfeeding women	Blood and milk samples	Mothers over 18, treated with amoxicillin alone or associated with clavulanic acid for at least 2 days, breastfeeding their child.

Primary Outcome Measures

Name	Time	Method
Concentration-time profile of amoxicillin in plasma	At the time of samplings (day 0)
Concentration-time profile of amoxicillin in milk	At the time of samplings (day 0)

Secondary Outcome Measures

Name	Time	Method
Occurrence of predefined side effects in infants during the breastfeeding period.	At the time of samplings (day 0) and a week later (day 7)	Occurrence of diarrhoea, nausea, vomiting, feeding difficulties, skin rashes, urticaria and candidiasis will be monitored using a form on the infant's health status and breastmilk production will be completed by the mother/parent at the time of samplings and a week later.
Impact of mother's drug consumption on breast milk production.	At the time of samplings (day 0) and a week later (day 7)	A form on breastmilk production will be completed by the mother/parent at the time of samplings and a week later

Trial Locations

Locations (2)

APHP Hôpital Necker, Lactarium Régional d'Ile de France; 🇫🇷 Paris, France

CHU Toulouse; 🇫🇷 Toulouse, France