Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
200 participants
OBSERVATIONAL
2019-02-05
2021-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Pharmacometrics Analysis of Rivaroxaban in Chinese Children Aged Over 2 Years
NCT06993636
Pharmacokinetic Study of the Association of Amoxicillin / Clavulanic Acid to Obese Adults
NCT02571959
Pharmacokinetics (PK) Study of Gepotidacin (GSK2140944) in Adult Subjects With Varying Degrees of Hepatic Impairment and in Matched Control Subjects With Normal Hepatic Function
NCT03562117
Pharmacokinetic Study of Gepotidacin in Subjects With Varying Degrees of Renal Impairment and in Subjects With Normal Renal Function
NCT02729038
Pharmacokinetics of Gepotidacin Tablets in Adults and Adolescents Subjects
NCT04079790
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
OTHER
PROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* No parental opposition to the study participation
Exclusion Criteria
44 Weeks
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Rennes University Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CHU Rennes
Rennes, , France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
35RC18-9874
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.