Safety Analysis of Antimicrobial Pharmacotherapy in Intensive Care Unit at Pediatric Hospital
NCT ID: NCT04141657
Last Updated: 2022-03-18
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
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COMPLETED
100 participants
OBSERVATIONAL
2020-02-01
2021-10-15
Brief Summary
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Detailed Description
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To assess the secondary endpoint for the general population - the frequency and timing of the transition to de-escalation at ICU, cluster analysis will be conducted to identify the relationship of specific AMA combinations with the possibility of de-escalation in ICU children.
Studies will be conducted to reveal the relationship in gene polymorphism encoding isoenzymes of the cytochrome P-450 biotransformation, and the relationship between the activity of transport proteins with the indicators of effectiveness and safety of antimicrobial pharmacotherapy. The lack of pharmacological safety studies in children administered medicine combinations to overcome pan-resistant gram-negative infection provides relevant prerequisites for this study.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Group 1 (0-17 years)
We will observe the treatment course in ICU pediatric patients, register adverse events (AEs) and serious adverse events (SAEs) if occur, and assess patient health status at the end of the performed therapy.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
2. Previous/concomitant therapy is not significant;
3. Children in the ward: children under guardianship are not eligible.
17 Years
ALL
No
Sponsors
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Russian Medical Academy of Continuous Professional Education
UNKNOWN
Morozov Children's Municipal Clinical Hospital of the Moscow City Health Department State-Financed
UNKNOWN
Anna Vlasova
OTHER_GOV
Responsible Party
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Anna Vlasova
PhD, chief of Clinical Pharmacology department
Principal Investigators
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Anna Vlasova, PhD, MD
Role: PRINCIPAL_INVESTIGATOR
Morozov Children's City Clinical Hospital of the Moscow City Health Department
Locations
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Morozov Children's City Clinical Hospital
Moscow, , Russia
Countries
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References
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Other Identifiers
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07819001
Identifier Type: -
Identifier Source: org_study_id
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