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Safety Analysis of Antimicrobial Pharmacotherapy in Intensive Care Unit at Pediatric Hospital

NCT04141657 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2022-03-18

No results posted yet for this study

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).

Conditions

  • Drug Therapy

Interventions

OTHER

Pharmacogenetic test

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.

Sponsors & Collaborators

  • Russian Medical Academy of Continuous Professional Education

    collaborator UNKNOWN

  • Morozov Children's Municipal Clinical Hospital of the Moscow City Health Department State-Financed

    collaborator UNKNOWN

  • Anna Vlasova

    lead OTHER_GOV

Principal Investigators

  • Anna Vlasova, PhD, MD · Morozov Children's City Clinical Hospital of the Moscow City Health Department

Eligibility

Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-02-01
Primary Completion
2021-08-28
Completion
2021-10-15

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04141657 on ClinicalTrials.gov