Population Pharmacokinetics of Metronidazole in Neonates
NCT ID: NCT04031183
Last Updated: 2020-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
160 participants
OBSERVATIONAL
2020-05-29
2022-03-31
Brief Summary
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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.
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Detailed Description
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* Opportunistic sampling strategy: no biological samples are specifically collected for the purposes of the study (measurements of concentrations on "bottoms" or "left-over" samples); the performance of this non-invasive sampling strategy has been previously demonstrated in the neonatal population.
* Micro-analytical method (assay of concentrations on micro-volumes, of the order of 50μL)
* Population pharmacokinetic analysis
Conditions
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Study Design
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OTHER
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
44 Weeks
ALL
No
Sponsors
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Rennes University Hospital
OTHER
Responsible Party
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Locations
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CHU d'Angers
Angers, , France
CHU de Brest
Brest, , France
Centre Robert Debré
Paris, , France
CHU de Rennes
Rennes, , France
CH St Brieuc
Saint-Brieuc, , France
CHU de Tours
Tours, , France
CH Vannes
Vannes, , France
Countries
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Central Contacts
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Facility Contacts
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Bernard LEBOUCHER
Role: primary
Jean-Michel ROUE
Role: primary
Valérie BIRAN
Role: primary
Jennifer CHAUVEL
Role: primary
Géraldine FAVRAIS
Role: primary
Anna SEVESTRE
Role: primary
Other Identifiers
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35RC18_8856_METROPOP
Identifier Type: -
Identifier Source: org_study_id
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