CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 100 enrolled
Drug / intervention
Pharmacogenetic testother
Likely dose
Not stated in record
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Search/NCT04141657
NCT04141657N/ACompleted

Observational Prospective Multidirectional Study on the Safety of Antimicrobial Pharmacotherapy in Intensive Care Unit (ICU) Children Aged 0-17

Anna Vlasova·observational·Posted Oct 28, 2019·Updated Mar 18, 2022

In Brief

An observational study evaluating Pharmacogenetic test for Drug Therapy. Completed, enrolled 100 participants across 1 site.

Detailed Summary

Changes in the metabolic ability of cytochrome P-450 during child development can affect both bioavailability and elimination depending on the involvement of intestinal and hepatic metabolic processes. The age-related variability of cytochrome P-450 isoenzymes in children has been described since 2010. The variability in the development of the activity of specific cytochrome P-450 isoenzymes illustrates why the pharmacogenetic features of the medicine use at different age periods should be studied for individual drugs. This will provide an understanding of the mechanisms for preventing adverse events appearing in pediatric intensive care units while more common antimicrobial pharmacotherapy is administered. Improved knowledge of the pharmacogenetic characteristics of cytochrome P-450 and the unintended consequences of modulation of its isoenzymes could provide an understanding of the susceptibility to adverse events in children in critical conditions staying at Intensive Care unit (ICU).

Study Details

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedOct 28, 2019
Enrollment StartFeb 1, 2020
Primary CompletionAug 28, 2021
Study CompletionOct 15, 2021
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 6.7 years ago

Interventions

Pharmacogenetic testother

Buccal swabs are a relatively non-invasive way to collect deoxyribonucleic acid (DNA) samples for testing. A buccal swab will be performed to collect DNA from the cells on the inside of a subject's cheek for phenotyping of CYP3A4.