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

NCT ID: NCT05051787

Last Updated: 2023-08-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-23
• Study Completion Date: 2023-07-12

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.

Conditions

Breast Feeding, Exclusive

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Breastfeeding women

Mothers over 18, treated with amoxicillin alone or associated with clavulanic acid for at least 2 days, breastfeeding their child.

Group Type: EXPERIMENTAL

Blood and milk samples

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peggy Gandia, MD

Role: STUDY_CHAIR

University Hospital, Toulouse

Locations

APHP Hôpital Necker, Lactarium Régional d'Ile de France

Paris, , France

CHU Toulouse

Toulouse, , France

Countries

France

Other Identifiers

RC31/21/0217

Identifier Type: -

Identifier Source: org_study_id