Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Achievement rate of therapeutic efficacy target of metronidazole | 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. | 1 week |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events | Recording of adverse events (clinical and / or biological) during the treatment period and up to the end of the hospitalisation | 1 week |
| Minimum Inhibitory Concentration |
Not provided
Inclusion Criteria:
Non-Inclusion Critéria Treatment with metronidazole initiated before arrival in the investigative center (> 1 dose).
Exclusion Criteria:
Not provided
Not provided
Not provided
Neonates (including both preterm and full-term neonates) receiving amoxicillin as part of their routine clinical care (for suspected or proven neonatal sepsis).
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU d'Angers | Angers | France | ||||
| CHU de Brest |
Not provided
| ID | Term |
|---|---|
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
Blood or peritoneal fluid drawn for routine biochemical tests
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
| 1 week |
| Concentration of metronidazole un peritoneal fluid | 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 | 1 week |
| average clearance | 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 | 1 week |
| Impact of age | 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 | 1 week |
| Impact of weight | 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 | 1 week |
| Impact of therapeutic associations | 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 | 1 week |
| volume of distribution | 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 | 1 week |
| interindividual variability | 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 | 1 week |
| residual variability | 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 | 1 week |
| 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 |