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 amoxicillin 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 amoxicillin | Achievement rate of therapeutic efficacy target of amoxicillin (ie percentage of neonates in whom amoxicillin 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 amoxicillin 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 |
|---|---|---|
| Recording of Adverse Events | Recording of adverse events (clinical and / or biological) during the treatment period and up to 96 hours after the end of treatment | 1 week |
| Minimum Inhibitory Concentration |
Not provided
Inclusion Criteria:
Exclusion Criteria:
• None
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).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Stuart Byrom | Contact | 0033 (0)299284312 | stuart.BYROM@chu-rennes.fr | |
| Stephanie Leroux, Phd | Contact | 0033 (0)299284312 | Stephanie.LEROUX@chu-rennes.fr |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Rennes | Recruiting | Rennes | 35000 | France |
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 cerebrospinal fluid drawn for routine biochemical tests
Collection of MICs of amoxicillin for isolated germs. For amoxicillin 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 amoxicilin in Cerebrospinal Fluid (CSF) | Calculation of amoxicillin concentration in CSF / amoxicillin plasma concentration when data permits (i.e. when lumbar puncture is performed as part of usual care, during treatment with amoxicillin | 1 week |