Last reviewed · How we verify
NCT05051787: CONCEPTION
Evaluation of Amoxicillin Diffusion in Breast Milk According to a Population Pharmacokinetic Approach (CONCEPTION-AMOX)
Phase 4 trial testing Blood and milk samples in Breast Feeding, Exclusive in 25 participants. Completed in 12 July 2023.
12 July 2023
Quick facts
| Lead sponsor | University Hospital, Toulouse |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 25 |
| Start date | 23 June 2022 |
| Primary completion | 12 July 2023 |
| Estimated completion | 12 July 2023 |
| Sites | 2 locations across France |
Drugs / interventions tested
- Blood and milk samples — full drug profile →
Conditions studied
- Breast Feeding, Exclusive — all drugs for Breast Feeding, Exclusive →
Sponsor
University Hospital, Toulouse
Who can join
18 and older, female only, with Breast Feeding, Exclusive. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05051787
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Breast Feeding, Exclusive
Currently open trials in the same condition.
- NCT05665049 — Social Transfers for Exclusive Breastfeeding · NA · active not recruiting
- NCT05486663 — Tactile/kinesthetic Stimulus Program · NA · recruiting
Other University Hospital, Toulouse trials
Trials by the same sponsor.
- NCT07497750 — Impact of Artificial Intelligence Algorithm-driven Versus Standard Lifestyle Intervention in Non-Alcoholic Fatty Liver D · NA · not yet recruiting
- NCT07507240 — The Benefits of a Care Pathway Combining Remote Monitoring and Support From a Nurse After a Change in Anti-epileptic Tre · NA · not yet recruiting
- NCT07524088 — Contamination of Young Children Hair During Acute Cannabis Intoxication · NA · not yet recruiting
- NCT07470580 — Radiofrequency Ablation Versus Adrenalectomy for Adenoma in Patients With Primary Aldosteronism and Hypertension · NA · not yet recruiting
- NCT07423988 — Evaluation of Changes in Sleep Efficiency Among PIC DU MIDI Staff Between Nights Spent at Home and Nights Spent in the W · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05051787 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Hospital, Toulouse
- Last refreshed: 23 August 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05051787.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing