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Population Pharmacokinetics of Anti-infectives in Critically Ill Children

NCT02539407 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 3000

Last updated 2025-11-20

No results posted yet for this study

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.

Conditions

  • Pediatric Intensive Care Unit
  • Pediatric Immuno-hematology Department

Interventions

OTHER

Pharmacokinetics

Sponsors & Collaborators

  • URC-CIC Paris Descartes Necker Cochin

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Oualha Mehdi, MD,PhD · Hospital Necker - Enfants Malades

  • Jean-Marc Treluyer, MD, PhD · EA08 Paris Descartes Pharmacologie et Evaluation des thérapeutiques chez l'enfant et la femme enceinte

Eligibility

Min Age
1 Day
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-11
Primary Completion
2028-10-31
Completion
2028-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02539407 on ClinicalTrials.gov