Clinical trial NCT01344512: Population Pharmacokinetics of Anti-infectious Drugs in Children
Official title: Population Pharmacokinetics Of Ceftazidime, Ciprofloxacin And Voriconazole In Paediatric Young Patients (< 12 Years Old)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pediatrics
Ceftazidime
Ciprofloxacin
Voriconazole
Keywords: Pharmacokinetic
Population
Children
Ceftazidime
Ciprofloxacin
Voriconazole
Pediatric
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2011-04-29
Enrollment: 214
Sex: ALL
Minimum age (years): 28
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Pharm A project is a French national collaborative project aiming to determine the population pharmacokinetics of ceftazidime, ciprofloxacin, and voriconazole in paediatric patients aged one month to five years.

Detailed description: The licensing process was introduced in order to ensure that medicines are safe, effective and of high quality. However, over 50% of children admitted to hospital in France and Europe will receive an unlicensed or off-label medicine. This occurs for most drugs in children less than 6 years of age. They represent a particularly vulnerable subgroup of the paediatric population.

There are major practical and ethical issues in relation to studying medicines in paediatric patients aged 5 years or less.

* They represent only a small part of the population as compared to older children and adults, and the variation of specific types of diseases in this young subpopulation is higher than in the paediatric counterpart. There are major differences in drug disposition in the different age groups.
* There is a need for suitable methodological approaches for clinical trials
* There are major ethical issues It is essential, therefore, to recruit children from various regions in France in order to obtain a critical sample size of sufficient magnitude and to conduct scientific sound studies. This will be achieved by performing Pharm A, a population pharmacokinetic study of three different anti infectious agents (ceftazidime, ciprofloxacin, voriconazole) and identify covariates including pharmacogenetic biomarkers that explain pharmacokinetic variability.

After parental informed consent, sampling strategy will be randomized depending on the drug and the age group (2 samples in patients below 2 years and 3 samples in patients from 2 to 5 years).

Eligibility criteria: Inclusion Criteria:

* Children aged 28 days to 11 years (\< 12 years)
* Receiving one of the following drugs for therapeutic reasons : ceftazidime, ciprofloxacin, voriconazole
* Representative for the clinician, a condition requiring the use of these molecules
* Informed consent signed by the two parents or legal representative
* Child affiliated to the national social security system

Exclusion Criteria:

Not Applicable

Primary outcomes:
measure: Population pharmacokinetic parameters and factors explaining variability
timeFrame: Between 2 and 4 days after the begining of the treatment
Secondary outcomes:
measure: Covariability factors explaining the variability (age, biological data, pharmacokinetics factors, associated treatments...)
timeFrame: Between 2 and 4 days after the beginning of the treatment
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU de Bordeaux, Hôpital Pellegrin
city: Bron
country: France
facility: Hospices Civils de Lyon
city: Clermont Ferrand
country: France
facility: CHU Clermont Ferrand
city: Dijon
country: France
facility: CHU de Dijon
city: Grenoble
country: France
facility: CHU de Grenoble
city: Lille
country: France
facility: CHRU Lille
city: Marseille
country: France
facility: AP-HM, Hôpital La Timone
city: Montpellier
country: France
facility: CHU Montpellier
city: Paris
country: France
facility: APHP - Hôpital NEcker
city: Paris
country: France
facility: AP-HP - Hôpital Robert Debré
city: Poitiers
country: France
facility: CHU Poitiers
city: Rouen
country: France
facility: CHU Rouen
city: Toulouse
country: France
facility: CHU Toulouse
city: Tours
country: France
facility: CHU tours
Study officials:
affiliation: University Hospital Bordeaux, France
name: Stéphanie Bui, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bui S, Facchin A, Ha P, Bouchet S, Leroux S, Nacka F, Fayon M, Jacqz-Aigrain E. Population pharmacokinetics of ceftazidime in critically ill children: impact of cystic fibrosis. J Antimicrob Chemother. 2020 Aug 1;75(8):2232-2239. doi: 10.1093/jac/dkaa170.