MedTrace Logo

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

NCT05051787 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2023-08-23

No results posted yet for this study

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.

Conditions

  • Breast Feeding, Exclusive

Interventions

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.

Sponsors & Collaborators

  • University Hospital, Toulouse

    lead OTHER

Principal Investigators

  • Peggy Gandia, MD · University Hospital, Toulouse

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-06-23
Primary Completion
2023-07-12
Completion
2023-07-12

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05051787 on ClinicalTrials.gov