Status:
UNKNOWN
Population Pharmacokinetics of Metronidazole in Neonates
Lead Sponsor:
Rennes University Hospital
Conditions:
Emergencies
Eligibility:
All Genders
Up to 44 years
Brief Summary
The objective of NEOPOPI is to conduct a population pharmacokinetic study of metronidazole in neonates, in order to evaluate and optimize neonatal dose regimen. There will be no change to the medicat...
Detailed Description
* Administration of the antibiotic according to the usual procedures for prescribing services: in particular, neither the indications nor the doses nor the methods of administration are fixed by the p...
Eligibility Criteria
Inclusion
- In case of birth at gestational age ≥ 37 weeks of amenorrhea (SA): inclusion of children of postnatal age \<28 days
- In case of birth at a gestational age \<37 SA: inclusion of post-menstrual age children (ie gestational age + post-natal age) \<44 SA 2. Benefiting from metronidazole antibiotic therapy, as part of their routine independent clinical management of the study, whether the targeted infection is suspected or proven 3. Social Security Affiliates 4. No opposition of parents to participation in the study
- Non-Inclusion Critéria Treatment with metronidazole initiated before arrival in the investigative center (\> 1 dose).
Exclusion
- None
Key Trial Info
Start Date :
May 29 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2022
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT04031183
Start Date
May 29 2020
End Date
March 1 2022
Last Update
July 28 2020
Active Locations (7)
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1
CHU d'Angers
Angers, France
2
CHU de Brest
Brest, France
3
Centre Robert Debré
Paris, France
4
CHU de Rennes
Rennes, France