Population Pharmacokinetics of Metronidazole in Neonates
METROPOP
1 other identifier
observational
160
1 country
7
Brief Summary
The objective of NEOPOPI is to conduct a population pharmacokinetic study of metronidazole 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 P50-P75 for all trials
Started May 2020
7 active sites
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
July 1, 2019
CompletedFirst Posted
Study publicly available on registry
July 24, 2019
CompletedStudy Start
First participant enrolled
May 29, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2022
CompletedJuly 28, 2020
March 1, 2020
1.8 years
July 1, 2019
July 27, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Achievement rate of therapeutic efficacy target of metronidazole
Achievement rate of therapeutic efficacy target of Metronidazole (ie percentage of neonates in whom metronidazole 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 metronidazole 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 (10)
Number of Adverse Events
1 week
Minimum Inhibitory Concentration
1 week
Concentration of metronidazole un peritoneal fluid
1 week
average clearance
1 week
Impact of age
1 week
- +5 more secondary outcomes
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 not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
CHU d'Angers
Angers, France
CHU de Brest
Brest, France
Centre Robert Debré
Paris, France
CHU de Rennes
Rennes, France
CH St Brieuc
Saint-Brieuc, France
CHU de Tours
Tours, France
CH Vannes
Vannes, France
Biospecimen
Blood or peritoneal 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
July 1, 2019
First Posted
July 24, 2019
Study Start
May 29, 2020
Primary Completion
March 1, 2022
Study Completion
March 1, 2022
Last Updated
July 28, 2020
Record last verified: 2020-03