Breast Feeding, ExclusivePhase 4CONCEPTIONNCT05051787
Evaluation of Amoxicillin Diffusion in Breast Milk According to a Population Pharmacokinetic Approach (CONCEPTION-AMOX)
A Phase 4 study testing Blood and milk samples in people with Breast Feeding, Exclusive, run by University Hospital, Toulouse at 2 sites in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Feeding, Exclusive
- What is being tested?
- Blood and milk samples
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesFrance
- Study dates
- 23 Jun 2022to 12 Jul 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
2 sites in 1 country.
France2 sites
APHP Hôpital Necker, Lactarium Régional d'Ile de France
Paris
CHU Toulouse
Toulouse
About this study
Official title: Evaluation of Amoxicillin Diffusion in Breast Milk According to a Population Pharmacokinetic Approach.
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.
Read the 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.
- Conditions
- Breast Feeding, Exclusive
- Being tested
- Blood and milk samples
- Keywords
- amoxicillin, population pharmacokinetic model
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood and milk samplesBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| Breastfeeding women | Experimental | Mothers over 18, treated with amoxicillin alone or associated with clavulanic acid for at least 2 days, breastfeeding their child. Receives: Biological: Blood and milk samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration-time profile of amoxicillin in milk
Measured: At the time of samplings (day 0)
Concentration-time profile of amoxicillin in plasma
Measured: At the time of samplings (day 0)
Secondary outcomes (2)
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.
Measured: At the time of samplings (day 0) and a week later (day 7)
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
Measured: At the time of samplings (day 0) and a week later (day 7)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2021
- Study start23 Jun 2022
- Primary completion12 Jul 2023
- Study completion12 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Feeding, ExclusiveStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peggy Gandia, MD, Study chair, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05051787
- Sponsor's protocol ID
- RC31/21/0217
- Acronym
- CONCEPTION
- Status last verified
- Aug 2023
- First submitted
- 2 Jul 2021
- Last updated
- 23 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Amoxicillin Diffusion in Breast Milk According to a Population Pharmacokinetic Approach.
- ClinicalTrials.gov ID
- NCT05051787
- Acronym / sponsor ID
- CONCEPTION / RC31/21/0217
- Conditions
- Breast Feeding, Exclusive
- Keywords
- amoxicillin, population pharmacokinetic model
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 23 Jun 2022 (actual)
- Primary completion
- 12 Jul 2023 (actual)
- Study completion
- 12 Jul 2023 (actual)
- First posted
- 21 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breastfeeding women | Experimental | Biological: Blood and milk samplesMothers over 18, treated with amoxicillin alone or associated with clavulanic acid for at least 2 days, breastfeeding their child. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood and milk samples2 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. | Biological | Breastfeeding women |
Primary outcome
Concentration-time profile of amoxicillin in milk
Time frame: At the time of samplings (day 0)
Concentration-time profile of amoxicillin in plasma
Time frame: At the time of samplings (day 0)
2 secondary outcomes
Occurrence of predefined side effects in infants during the breastfeeding period.
Time frame: At the time of samplings (day 0) and a week later (day 7)
Impact of mother's drug consumption on breast milk production.
Time frame: At the time of samplings (day 0) and a week later (day 7)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peggy Gandia, MD study chair
University Hospital, Toulouse
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Blood and milk samples in people with Breast Feeding, Exclusive, run by University Hospital, Toulouse at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concentration-time profile of amoxicillin in milk (time frame: At the time of samplings (day 0)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2023.