← Eichor
Study identifier: NCT02539407 Synced from ClinicalTrials.gov · July 28, 2026
● Recruiting

Population Pharmacokinetics of Anti-infectives in Critically Ill Children

Condition: Pediatric Intensive Care Unit · Pediatric Immuno-hematology Department  ·  Sponsor: Assistance Publique - Hôpitaux de Paris

PhaseN/A
Planned participants3000
Who can joinAll sexes, 1 Day to 18 Years
Healthy volunteersNo

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Oualha Mehdi, MD,PhD  ·  +33171196082  ·  mehdi.oualha@nck.aphp.fr

Laure Choupeaux  ·  +33 1 44 38 17 11  ·  laure.choupeaux@aphp.fr

Always discuss trial participation with your own doctor first.

Locations (1)

Hospital Necker - Enfants Malades (Public Hospitals of Paris)Paris, FranceRecruiting

Follow this study

Get one email when the public record changes — results posted, or the study's status changes. Nothing else, ever.

We email about this public record only. Unsubscribe anytime with one click. Never medical advice.

Is this your study? This page was generated automatically from the public registry record. Sponsors can claim it — free — to add branding and verified contact routing. Claim this page →

This page is independently generated by Eichor from the public ClinicalTrials.gov record and re-synced daily. It is not the sponsor's official website unless claimed. Nothing here is medical advice; eligibility is always determined by the study team — talk to your own doctor first.

Source record: clinicaltrials.gov/study/NCT02539407