RecruitingNCT02539407

Population Pharmacokinetics of Anti-infectives in Critically Ill Children

Population Pharmacokinetics and Rationalization of Anti-infectives Administration in Critically Ill Children


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

3,000 participants

Start Date

Sep 11, 2015

Study Type

OBSERVATIONAL

Conditions

Summary

Concentrations and effects of anti-infectives in critically ill children are unpredictable and the risk of under-exposure may be associated with poor clinical outcomes. In addition, between-subject variability (BSV) is known to be substantial in critically ill children. Rationalisation of anti-infectives in children is therefore desirable. The investigators aim to investigate, using a population approach, the pharmacokinetics (PK) and pharmacodynamics (PD) of anti-infectives including PK/PD targets (fT(%) \> minimal inhibitory concentration (MIC)) and PD endpoints (clinical outcomes) in critically ill children. Covariates The effects of covariates on anti-infectives PK and PK/PDs are investigated in order to better explain the BSV and to ultimately suggest individualized dosage regimens. It will be a prospective PK study including 11 anti-infectives antibiotics. Six blood samples were taken from each patient during dosing interval. The primary PK/ PD targets were anti-infectives concentrations above the MIC of the pathogen at both 50% (50% f T\>MIC) and 100% (100% f T\>MIC) of the dosing interval. The investigators used skewed logistic regression to describe the effect of anti-infectives exposure on patient outcome.


Eligibility

Min Age: 1 DayMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study measures how antibiotic and antifungal medications behave in the bodies of critically ill children (pharmacokinetics) to help optimize dosing. Standard adult doses may not work the same way in children, and this study aims to improve how these drugs are dosed in pediatric ICU patients. You may be eligible if: - Your child is under 18 years old - Your child is receiving one of several specific antibiotics or antifungals during hospitalization or follow-up care - Your child is 1 day of age or older You may NOT be eligible if: - You or your child's parents have explicitly refused participation and data collection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERPharmacokinetics

Locations(1)

Hospital Necker - Enfants Malades (Public Hospitals of Paris)

Paris, France

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NCT02539407


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