Emergencies Clinical Trial
Official title:
Population Pharmacokinetics of Amoxicillin in Neonates: Evaluation and Optimization of the Dose
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.
- 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
;
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