Population Pharmacokinetics of Amoxicillin in Neonates
NEOPOPI
1 other identifier
observational
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2019
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 9, 2019
CompletedStudy Start
First participant enrolled
February 5, 2019
CompletedFirst Posted
Study publicly available on registry
June 14, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2021
CompletedJune 14, 2019
June 1, 2019
2.5 years
January 9, 2019
June 13, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Recording of Adverse Events
1 week
Minimum Inhibitory Concentration
1 week
Concentration of amoxicilin in Cerebrospinal Fluid (CSF)
1 week
Eligibility Criteria
Neonates (including both preterm and full-term neonates) receiving amoxicillin as part of their routine clinical care (for suspected or proven neonatal sepsis).
You may qualify if:
- Neonates receiving amoxicillin and blood/CSF tests during amoxicillin treatment, as part of their routine clinical care
- No parental opposition to the study participation
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Rennes
Rennes, 35000, France
Biospecimen
Blood or cerebrospinal fluid drawn for routine biochemical tests
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2019
First Posted
June 14, 2019
Study Start
February 5, 2019
Primary Completion
August 1, 2021
Study Completion
August 1, 2021
Last Updated
June 14, 2019
Record last verified: 2019-06