Population Pharmacokinetics of Amoxicillin in Neonates

Emergencies Clinical Trial

— NEOPOPI  

Official title:

Population Pharmacokinetics of Amoxicillin in Neonates: Evaluation and Optimization of the Dose

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03987100
• Other study ID #: 35RC18-9874
• Status: Recruiting
• Start date: February 5, 2019
• Est. completion date: August 2021

Study information

• Verified date: June 2019
• Source: Rennes University Hospital
• Contact: Stuart Byrom
• Phone: 0033 (0)299284312
• Email: stuart.BYROM[@]chu-rennes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 44 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Emergencies

Locations

Country	Name	City	State
France	CHU Rennes	Rennes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Minimum Inhibitory Concentration	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
Secondary	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