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Population Pharmacokinetics of Anti-infectives in Critically Ill Children

ConditionsPediatric Intensive Care UnitPediatric Immuno-hematology Department
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-18
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Minor patients requiring the administration of anti-infectives

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Pharmacokinetics

    Other intervention

Treatment groups

3,000 Participants
are divided into 1 treatment group
Group A: Anti-infectives1 intervention

Trial outcomes

Primary outcomes

1

anti-infectives concentration

Time frame
until 28 days

Secondary outcomes

1

number of identified or suspected pathogen

Time frame
until 28 days
2

composite measure of the health condition

Clinical data: anthropometric characteristics, organs function, severity score, clinical cure

Time frame
until 28 days
3

predictive variables of underdosing/overdosing of antiinfectives and biological evolution

Clinical data: anthropometric characteristics, organs function, severity score, clinical cure

Time frame
until 28 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

URC-CIC Paris Descartes Necker Cochin

Collaborator

Source ClinicalTrials.gov
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