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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breastfeeding women | Experimental | Mothers over 18, treated with amoxicillin alone or associated with clavulanic acid for at least 2 days, breastfeeding their child. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peggy Gandia, MD | University Hospital, Toulouse | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| APHP Hôpital Necker, Lactarium Régional d'Ile de France | Paris | France | ||||
| CHU Toulouse |
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| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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|
| 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) |
| Toulouse |
| France |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |