Clinical trial NCT05051787: Evaluation of Amoxicillin Diffusion in Breast Milk According to a Population Pharmacokinetic Approach (CONCEPTION-AMOX)
Official title: Evaluation of Amoxicillin Diffusion in Breast Milk According to a Population Pharmacokinetic Approach.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Breast Feeding, Exclusive
Keywords: amoxicillin
population pharmacokinetic model
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2021-09-21
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Concentration-time profile of amoxicillin in milk
timeFrame: At the time of samplings (day 0)
measure: Concentration-time profile of amoxicillin in plasma
timeFrame: At the time of samplings (day 0)
Secondary outcomes:
measure: Occurrence of predefined side effects in infants during the breastfeeding period.
timeFrame: At the time of samplings (day 0) and a week later (day 7)
measure: Impact of mother's drug consumption on breast milk production.
timeFrame: At the time of samplings (day 0) and a week later (day 7)
Other outcomes:
Locations:
city: Paris
country: France
facility: APHP Hôpital Necker, Lactarium Régional d'Ile de France
city: Toulouse
country: France
facility: CHU Toulouse
Study officials:
affiliation: CHU Toulouse
name: Peggy Gandia, MD
role: STUDY_CHAIR
References: