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Completed

NCT Number: NCT04031183

Population Pharmacokinetics of Metronidazole in Neonates

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.

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Key information

Conditions

Emergencies Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

Up to 44 week

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU d'Angers, Angers, France

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About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

  1. Achievement rate of therapeutic efficacy target of metronidazole

    Time frame: 1 week

    Achievement rate of therapeutic efficacy target of Metronidazole (ie percentage of neonates in whom metronidazole plasma concentration remains above the MIC of target organisms for more than 70% of the dose range). In accordance with the recommendations of the European Medicines Agency, the optimal dosage regimen is defined as leading to a probability of antibiotic therapy success of greater than or equal to 90%. Thus, it is necessary to determine the dosage regimen allowing the target of therapeutic efficacy to be reached (ie maintenance of the plasma concentration of metronidazole greater than the MIC of the targeted microorganisms for more than 70% of the dose) in at least 90% of treated neonates.

Secondary outcomes

  1. Number of Adverse Events

    Time frame: 1 week

    Recording of adverse events (clinical and / or biological) during the treatment period and up to the end of the hospitalisation

  2. Minimum Inhibitory Concentration

    Time frame: 1 week

    Collection of MICs of metronidazole for isolated germs. For metronidazole the antibacterial activity is time-dependent, the predictor of efficacy is the "Time> MIC": this is the percentage of the administration interval during which the concentration of the antibiotic remains higher than the MIC of target germs

  3. Concentration of metronidazole un peritoneal fluid

    Time frame: 1 week

    Calculation of metronidazole concentration in peritoneal fluid / metronidazole plasma concentration when data permits (i.e. when prelevment performed as part of usual care, during treatment with metronidazole

  4. average clearance

    Time frame: 1 week

    Using the population pharmacokinetic model developed and validated (diagnostic plots, NPDE (Comets et al., 2008), and bootstrap), calculation of:

    • the precision of estimates of average clearance

  5. Impact of age

    Time frame: 1 week

    Using the population pharmacokinetic model developed and validated (diagnostic plots, NPDE (Comets et al., 2008), and bootstrap), calculation of:

    the impact of âge associations as explaining part of the pharmacokinetic variability of the antibiotic

  6. Impact of weight

    Time frame: 1 week

    Using the population pharmacokinetic model developed and validated (diagnostic plots, NPDE (Comets et al., 2008), and bootstrap), calculation of:

    the impact of weight as explaining part of the pharmacokinetic variability of the antibiotic

  7. Impact of therapeutic associations

    Time frame: 1 week

    Using the population pharmacokinetic model developed and validated (diagnostic plots, NPDE (Comets et al., 2008), and bootstrap), calculation of:

    the impact of therapeutic associations as explaining part of the pharmacokinetic variability of the antibiotic

  8. volume of distribution

    Time frame: 1 week

    Using the population pharmacokinetic model developed and validated (diagnostic plots, NPDE (Comets et al., 2008), and bootstrap), calculation of:

    • the precision of estimates of volume of distribution

  9. interindividual variability

    Time frame: 1 week

    Using the population pharmacokinetic model developed and validated (diagnostic plots, NPDE (Comets et al., 2008), and bootstrap), calculation of:

    • the precision of estimates of interindividual variability

  10. residual variability

    Time frame: 1 week

    Using the population pharmacokinetic model developed and validated (diagnostic plots, NPDE (Comets et al., 2008), and bootstrap), calculation of:

    • the precision of estimates of residual variability

Sponsors and collaborators

Lead sponsor

Rennes University Hospital

Other

Registry information

Official study title

Population Pharmacokinetics of Metronidazole in Neonates: Evaluation and Optimization of the Dose

Acronym: METROPOP

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 24, 2019
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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