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

NCT05051787 | Completed Phase 4

• 1 other identifier: RC31/21/0217
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Feeding, Exclusive

Keywords

amoxicillin; population pharmacokinetic model

Outcome Measures

Primary Outcomes (2)

• Concentration-time profile of amoxicillin in milk

  At the time of samplings (day 0)

• Concentration-time profile of amoxicillin in plasma

  At the time of samplings (day 0)

Secondary Outcomes (2)

• Occurrence of predefined side effects in infants during the breastfeeding period.

  At the time of samplings (day 0) and a week later (day 7)

• Impact of mother's drug consumption on breast milk production.

  At the time of samplings (day 0) and a week later (day 7)

Study Arms (1)

Breastfeeding women

EXPERIMENTAL

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

Biological: Blood and milk samples

Interventions

Blood and milk samples 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.

Breastfeeding women

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (2)

APHP Hôpital Necker, Lactarium Régional d'Ile de France

Paris, France

Location

CHU Toulouse

Toulouse, France

Location

MeSH Terms

Conditions

Breast Feeding

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Peggy Gandia, MD

  University Hospital, Toulouse

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2021
• First Posted: September 21, 2021
• Study Start: June 23, 2022
• Primary Completion: July 12, 2023
• Study Completion: July 12, 2023
• Last Updated: August 23, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)