Breastfeeding
Conditions
Interventions
Trade Name: amoxicilline
Product Name: amoxicilline
Pharmaceutical Form: Tablet
Trade Name: Amoxicillin and clavulanic acid
Product Name: Amoxicillin and clavulanic acid
Pharmaceutical Form: Tablet
Sponsors
CHU TOULOUSE
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Mothers over 18, treated with Amoxicillin for at least 2 days, breastfeeding their child and living in an area covered by the authorization of one of the ethics committees concerned by this multicenter study will be eligible for the study, -Participation requires that breastfeeding has been started for at least 2 weeks after childbirth and that the infant is more than 4 weeks old, -Affiliation to the social security scheme or equivalent, -Ability to understand and willingness to sign a written informed consent document for withdrawal of plasma and milk. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: -Mothers under 18 years old, -Infants born prematurely (i.e. gestational age of less than 34 weeks) or requiring appropriate medical supervision or the support of a team of social workers, -Mothers who have given birth to twins, -Inability to communicate with mother due to language problems, -Patient subject to a legal protection order (curatorship or tutorship)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Describe the pharmacokinetics of Amoxicillin in lactating women, through the use of a population pharmacokinetic model, in order to (i) determine the kinetic profile of Amoxicillin in milk and its variability, (ii) identify the factors explaining this variability and (iii) predict the daily dose ingested by the infant and its associated variability according to different dosage regimens applied to the mother.;Secondary Objective: The secondary objectives are to monitor (i) the occurrence of predefined adverse reactions in infants during the lactation period, and (ii) the impact of Amoxicillin consumption on breast milk production.;Primary end point(s): Determination of: - The median area under the plasma drug concentration-time curve in the mother milk for Amoxicillin and percentage of change in mother milk drug levels according to demographics and other co-factors (e.g. co-medications). - The median dose ingested during breastfeeding by the new-born as well as the associated inter-individual variability, in various simulated conditions (e.g. full or mixed breastfeeding; factors influencing infant drug exposure). ;Timepoint(s) of evaluation of this end point: At the end of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Occurrence of predefined side effects in infants and of decrease of breast milk production recorded at sampling and a week later.;Timepoint(s) of evaluation of this end point: At the end of the study. | — |
Countries
France
Contacts
Public ContactClinical Research Assistant
CHU TOULOUSE
Outcome results
None listed