Clinical trial NCT04031183: Population Pharmacokinetics of Metronidazole in Neonates
Official title: Population Pharmacokinetics of Metronidazole in Neonates: Evaluation and Optimization of the Dose
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Emergencies
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2019-07-24
Enrollment: 160
Sex: ALL
Maximum age (years): 44
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neonates (including both preterm and full-term neonates) receiving amoxicillin as part of their routine clinical care (for suspected or proven neonatal sepsis).

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 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.

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 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

Eligibility criteria: 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

Primary outcomes:
measure: Achievement rate of therapeutic efficacy target of metronidazole
timeFrame: 1 week
Secondary outcomes:
measure: Number of Adverse Events
timeFrame: 1 week
measure: Minimum Inhibitory Concentration
timeFrame: 1 week
measure: Concentration of metronidazole un peritoneal fluid
timeFrame: 1 week
measure: average clearance
timeFrame: 1 week
measure: Impact of age
timeFrame: 1 week
measure: Impact of weight
timeFrame: 1 week
measure: Impact of therapeutic associations
timeFrame: 1 week
measure: volume of distribution
timeFrame: 1 week
measure: interindividual variability
timeFrame: 1 week
measure: residual variability
timeFrame: 1 week
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU d'Angers
city: Brest
country: France
facility: CHU de Brest
city: Paris
country: France
facility: Centre Robert Debré
city: Rennes
country: France
facility: CHU de Rennes
city: Saint-Brieuc
country: France
facility: CH St Brieuc
city: Tours
country: France
facility: CHU de Tours
city: Vannes
country: France
facility: CH Vannes
Study officials:
References: