Informations générales (source: ClinicalTrials.gov)
Population Pharmacokinetics of Metronidazole in Neonates: Evaluation and Optimization of the Dose (METROPOP)
Observational
Rennes University Hospital (Voir sur ClinicalTrials)
mai 2020
mars 2022
29 juin 2024
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 medication treatment received by participants. An
opportunistic pharmacokinetic sampling approach will be followed: samples will be
scavenged from blood or cerebrospinal fluid drawn for routine biochemical tests. In this
way, no additional invasive tests will be needed.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CH St Brieuc - Saint-Brieuc - France | Jennifer CHAUVEL | Contact (sur clinicalTrials) | |||
| CH Vannes - Vannes - France | Anna SEVESTRE | Contact (sur clinicalTrials) | |||
| CHU d'Angers - Angers - France | Bernard LEBOUCHER | Contact (sur clinicalTrials) | |||
| CHU de Brest - Brest - France | Jean-Michel ROUE | Contact (sur clinicalTrials) | |||
| CHU de Rennes - Rennes - France | Stéphanie LEROUX, Phd | Contact (sur clinicalTrials) | |||
| CHU de Tours - Tours - France | Géraldine FAVRAIS | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Robert Debré - Paris - France | Valérie BIRAN | Contact (sur clinicalTrials) | |||
Critères
Tous
Inclusion Criteria:
- 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).
- 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).
- None