Actively Recruiting
Population Pharmacokinetics of Anti-infectives in Critically Ill Children
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-11-20
3000
Participants Needed
1
Research Sites
690 weeks
Total Duration
On this page
Sponsors
A
Assistance Publique - Hôpitaux de Paris
Lead Sponsor
U
URC-CIC Paris Descartes Necker Cochin
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Population Pharmacokinetics of Anti-infectives in Critically Ill Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Minor patient requiring the administration of an anti-infective belonging to the following classes: beta-lactam antibiotics; aminoglycosides; glycopeptides; fluoroquinolones; other antibiotics (daptomycin, rifampin, trimethoprim, sulfamethoxazole, clarithromycin); antifungals; antivirals during follow-up or hospitalization
You will not qualify if you...
- Patient and parents have notified the doctor that they refuse data recovery
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hospital Necker - Enfants Malades (Public Hospitals of Paris)
Paris, France, 75015
Actively Recruiting
Research Team
O
Oualha Mehdi, MD,PhD
CONTACT
L
Laure Choupeaux
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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