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

Breast Feeding, Exclusive Clinical Trial

— CONCEPTION  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05051787
• Other study ID #: RC31/21/0217
• Status: Completed
• Phase: Phase 4
• Start date: June 23, 2022
• Est. completion date: July 12, 2023

Study information

• Verified date: August 2023
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: July 12, 2023
• Est. primary completion date: July 12, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Breast Feeding, Exclusive

Intervention

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.

Locations

Country	Name	City	State
France	APHP Hôpital Necker, Lactarium Régional d'Ile de France	Paris
France	CHU Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concentration-time profile of amoxicillin in milk		At the time of samplings (day 0)
Primary	Concentration-time profile of amoxicillin in plasma		At the time of samplings (day 0)
Secondary	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)
Secondary	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)