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

Plain-language summary

This study examines the safety of antimicrobial medications used to treat infections in a pediatric hospital's intensive care unit, with the help of pharmacogenetic testing. It enrolled children admitted to intensive care who had infections with a risk of multidrug-resistant organisms. The study was a non-phased study and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Completed

Sponsor

Anna Vlasova

Intervention

Pharmacogenetic test

Start date

2/1/2020

Estimated completion

10/15/2021

Countries

Russia

Related genes

Locations

• Moscow, Russia

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

Inclusion Criteria:

1. Intensive Care Unit (ICU) patient;
2. Community-acquired infections with risk factors for multidrug-resistant pathogens (risk factors for extended-spectrum β-lactamase (ESBL) - type II;
3. Nosocomial infections - type III:

   * IIIa: hospitalized during the period of 90 days, without prior antimicrobial agent (AMA) therapy outside the ICU (risk factors for ESBL);
   * IIIb: prolonged hospitalization (\> 7 days) and/or stay at ICU for more than 3 days and/or previous AMA therapy (risk factors for ESBL, carbenicillin-resistant (CARB-R), nonfermenting Gram-negative bacteria (NFGNB), methicillin-resistant Staphylococcus aureus (MRSA));
4. Nosocomial infections with a risk of invasive candidiasis - type IV (candida score ≥2 points);
5. Written informed consent for medical intervention signed by at least one parent or caregiver (legal guardian) or informed consent of a patient under 15 years of age;
6. Written informed consent for pharmacogenetic research signed by at least one parent or caregiver (legal guardian) or informed consent of a patient under 15 years of age.

Exclusion Criteria:

1. Type I: patients with community-acquired infections and without risk factors for multidrug-resistant pathogens, without hospitalization during the previous 90 days;
2. Previous/concomitant therapy is not significant;
3. Children in the ward: children under guardianship are not eligible.