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Population Pharmacokinetics of Anti-infectives in Critically Ill Children

Recruitingn/aAges 1 Day - 18 YearsAllAssistance Publique - Hôpitaux de Paris
NCT02539407 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * Patient and parents having notified to the doctor that they refuse data recovery.
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What it tests

  • Pharmacokinetics
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Where

1 site
Hospital Necker - Enfants Malades (Public Hospitals of Paris)
Paris, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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