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

Inclusion Criteria1

  • Minor patient requiring the administration of an anti-infective belonging to the following classes : β-lactam antibiotics; aminoglycosides, glycopeptides; fluoroquinolones; other antibiotics (daptomycin, rifampin, trimethoprim, sulfamethoxazole, clarithromycin); fungal; antivirals, during its follow-up or hospitalization

Exclusion Criteria1

  • Patient and parents having notified to the doctor that they refuse data recovery.

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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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