Population Pharmacokinetics of Metronidazole in Neonates

Last updated: July 27, 2020
Sponsor: Rennes University Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT04031183
35RC18_8856_METROPOP
  • Ages < 44
  • All Genders

Study 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 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • In case of birth at gestational age ≥ 37 weeks of amenorrhea (SA): inclusion ofchildren 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 metronidazoleantibiotic therapy, as part of their routine independent clinical management of thestudy, whether the targeted infection is suspected or proven 3. Social SecurityAffiliates 4. No opposition of parents to participation in the study Non-Inclusion Critéria Treatment with metronidazole initiated before arrival in theinvestigative center (> 1 dose).

Exclusion

Exclusion Criteria:

  • None

Study Design

Total Participants: 160
Study Start date:
May 29, 2020
Estimated Completion Date:
March 31, 2022

Study 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 protocol

  • 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

Connect with a study center

  • CHU d'Angers

    Angers,
    France

    Active - Recruiting

  • CHU de Brest

    Brest,
    France

    Active - Recruiting

  • Centre Robert Debré

    Paris,
    France

    Site Not Available

  • CHU de Rennes

    Rennes,
    France

    Active - Recruiting

  • CH St Brieuc

    Saint-Brieuc,
    France

    Site Not Available

  • CHU de Tours

    Tours,
    France

    Active - Recruiting

  • CH Vannes

    Vannes,
    France

    Site Not Available

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