Population Pharmacokinetics of Metronidazole in Neonates: Evaluation and Optimization of the Dose
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 171
- Locations
- 7
- Primary Endpoint
- Achievement rate of therapeutic efficacy target of metronidazole
Study Overview
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
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- — to 44 Weeks (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Benefiting from metronidazole antibiotic therapy, as part of their routine independent clinical management of the study, whether the targeted infection is suspected or proven
- •Social Security Affiliates
- •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
- Not provided
Outcomes
Primary Outcomes
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
- interindividual variability(1 week)
- average clearance(1 week)
- volume of distribution(1 week)
- residual variability(1 week)
- Number of Adverse Events(1 week)
- Impact of age(1 week)
- Impact of weight(1 week)
- Minimum Inhibitory Concentration(1 week)
- Concentration of metronidazole un peritoneal fluid(1 week)
- Impact of therapeutic associations(1 week)