Population Pharmacokinetics of Anti-infectious Drugs in Children
Information source: University Hospital, Bordeaux
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pediatrics; Ceftazidime; Ciprofloxacin; Voriconazole
Intervention: Ceftazidime (Drug); Ciprofloxacin (Drug); Voriconazole (Drug)
Phase: N/A
Status: Recruiting
Sponsored by: University Hospital, Bordeaux Official(s) and/or principal investigator(s):
Stéphanie Bui, Dr, Principal Investigator, Affiliation: University Hospital Bordeaux, France
Overall contact:
Stéphanie Bui, Dr, Phone: (33) 5 56 79 87 37, Email: stephanie.bui@chu-bordeaux.fr
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.
Clinical Details
Official title: Population Pharmacokinetics Of Ceftazidime, Ciprofloxacin And Voriconazole In Paediatric Young Patients (< 12 Years Old)
Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Population pharmacokinetic parameters and factors explaining variability
Secondary outcome: Covariability factors explaining the variability (age, biological data, pharmacokinetics factors, associated treatments...)
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
Minimum age: N/A.
Maximum age: 6 Years.
Gender(s): Both.
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
Locations and Contacts
Stéphanie Bui, Dr, Phone: (33) 5 56 79 87 37, Email: stephanie.bui@chu-bordeaux.fr
CHU de Bordeaux, Hôpital Pellegrin, Bordeaux 33076, France; Recruiting
Stéphanie BUI, Dr, Phone: (33) 5 56 79 87 37, Email: stephanie.bui@chu-bordeaux.fr
Stéphanie BUI, Dr, Principal Investigator
Michael FAYON, Pr, Sub-Investigator
Cécile VERITE, Dr, Sub-Investigator
Paul NOLENT, Dr, Sub-Investigator
Hospices Civils de Lyon, Bron 69500, France; Recruiting
Yves BERTRAND, Pr, Email: yves.bertrand@chu-lyon.fr
Yves BERTRAND, Pr, Principal Investigator
CHU Clermont Ferrand, Clermont Ferrand 63000, France; Recruiting
François Demeocq, Pr, Email: fdemeocq@chu-clermontferrand.fr
François Demeocq, Pr, Principal Investigator
CHU de Dijon, Dijon 21079, France; Recruiting
Marc BARDOU, Email: marc.Bardou@u-bourgogne.fr
Marc BARDOU, Pr, Principal Investigator
Frédéric HUET, Pr, Sub-Investigator
CHU de Grenoble, Grenoble 38043, France; Not yet recruiting
Isabelle PIN, Dr
Isabelle PIN, Dr, Principal Investigator
CHRU Lille, Lille 59037, France; Recruiting
Frédéric Gottrand, Pr
Frédéric GOTTRAND, Pr, Principal Investigator
AP-HM, Hôpital La Timone, Marseille 13005, France; Recruiting
Michel Tsimaratos, Pr
Michel Tsimaratos, Pr, Principal Investigator
CHU Montpellier, Montpellier 34925, France; Recruiting
Gilles Cambonie, Pr, Email: g-cambonie@chu-montpellier.fr
Gilles CAMBONIE, Pr, Principal Investigator
APHP - Hôpital NEcker, Paris 75015, France; Not yet recruiting
Jean-Marc Treluyer, Pr
Jean-Marc Treluyer, Pr, Principal Investigator
AP-HP - Hôpital Robert Debré, Paris 75019, France; Recruiting
Evelyne Jacz-Aigrain, Pr, Email: evelyne.jacqzaigrain@gmail.com
Evelyne Jacz-Aigrain, Pr, Principal Investigator
CHU Poitiers, Poitiers 86000, France; Recruiting
Régis Hankard, Dr, Email: r.hankard@chu-poitiers.fr
Régis HANKARD, Dr, Principal Investigator
CHU Rouen, Rouen 76031, France; Recruiting
Eric MALLET, Email: eric.mallet@chu-rouen.fr
Eric MALLET, Pr, Principal Investigator
CHU Toulouse, Toulouse 31059, France; Not yet recruiting
Jean-Pierre SALLES, Pr, Email: salle.jp@chu-toulouse.fr
Jean-Pierre SALLES, Pr, Principal Investigator
CHU tours, Tours 37044, France; Recruiting
François Labarthe, Email: labarthe@med.univ-tours.fr
François LABARTHE, Pr, Principal Investigator
Additional Information
Starting date: June 2011
Last updated: January 10, 2013
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