Population Pharmacokinetics of Amoxicillin in Neonates

• Conditions: Emergencies

• Registration Number: NCT03987100
• Lead Sponsor: Rennes University Hospital

Brief Summary

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.

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 Timeline

• Study First Submitted: 2019-01-09
• Study Start: 2019-02-05
• Status Verified: 2019-06
• Study First Submitted QC: 2019-06-13
• Last Update Submitted: 2019-06-13
• Study First Posted: 2019-06-14
• Last Update Posted: 2019-06-14
• Primary Completion: 2021-08
• Study Completion: 2021-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Neonates receiving amoxicillin and blood/CSF tests during amoxicillin treatment, as part of their routine clinical care
• No parental opposition to the study participation

Exclusion Criteria

• None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Achievement rate of therapeutic efficacy target of amoxicillin	1 week	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.

Secondary Outcome Measures

Name	Time	Method
Minimum Inhibitory Concentration	1 week	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
Concentration of amoxicilin in Cerebrospinal Fluid (CSF)	1 week	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
Recording of Adverse Events	1 week	Recording of adverse events (clinical and / or biological) during the treatment period and up to 96 hours after the end of treatment

Trial Locations

Locations (1)

CHU Rennes; 🇫🇷 Rennes, France