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

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Feeding, Exclusive
• Intervention / Treatment: Biological: Blood and milk samples

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 Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Paris, France
    • APHP Hôpital Necker, Lactarium Régional d'Ile de France
  • Toulouse, France
    • CHU Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Breastfeeding women; Mothers over 18, treated with amoxicillin alone or associated with clavulanic acid for at least 2 days, breastfeeding their child.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Concentration-time profile of amoxicillin in milk	At the time of samplings (day 0)
Concentration-time profile of amoxicillin in plasma	At the time of samplings (day 0)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occurrence of predefined side effects in infants during the breastfeeding period.	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.	At the time of samplings (day 0) and a week later (day 7)
Impact of mother's drug consumption on breast milk production.	A form on breastmilk production will be completed by the mother/parent at the time of samplings and a week later	At the time of samplings (day 0) and a week later (day 7)

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Study Chair: Peggy Gandia, MD, CHU Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2022
• Primary Completion (Actual): July 12, 2023
• Study Completion (Actual): July 12, 2023

Study Registration Dates

• First Submitted: July 2, 2021
• First Submitted That Met QC Criteria: September 9, 2021
• First Posted (Actual): September 21, 2021

Study Record Updates

• Last Update Posted (Actual): August 23, 2023
• Last Update Submitted That Met QC Criteria: August 22, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: amoxicillin; population pharmacokinetic model
• Other Study ID Numbers: RC31/21/0217

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No