Population Pharmacokinetics of Anti-infectious Drugs in Children
- Conditions
- CeftazidimeCiprofloxacinPediatricsVoriconazole
- Interventions
- Registration Number
- NCT01344512
- Lead Sponsor
- University Hospital, Bordeaux
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 214
- 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
Not Applicable
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Patients treated with Ceftazidime Ceftazidime - Patients treated with Voriconazole Voriconazole - Patients treated with Ciprofloxacin Ciprofloxacin -
- Primary Outcome Measures
Name Time Method Population pharmacokinetic parameters and factors explaining variability Between 2 and 4 days after the begining of the treatment Population Pharmacokinetic Parameters and variability factors (Sex, Age, Genetic factors...) for ceftazidime, ciprofloxacin and voriconazole.
According to the age of participants, 2 or 3 bloods sampling will be take between 2 and 4 days after the beginning of the treatment.
- Secondary Outcome Measures
Name Time Method Covariability factors explaining the variability (age, biological data, pharmacokinetics factors, associated treatments...) Between 2 and 4 days after the beginning of the treatment
Trial Locations
- Locations (14)
APHP - H么pital NEcker
馃嚝馃嚪Paris, France
CHU Poitiers
馃嚝馃嚪Poitiers, France
CHU de Dijon
馃嚝馃嚪Dijon, France
CHU de Bordeaux, H么pital Pellegrin
馃嚝馃嚪Bordeaux, France
CHU de Grenoble
馃嚝馃嚪Grenoble, France
CHRU Lille
馃嚝馃嚪Lille, France
CHU Montpellier
馃嚝馃嚪Montpellier, France
AP-HP - H么pital Robert Debr茅
馃嚝馃嚪Paris, France
Hospices Civils de Lyon
馃嚝馃嚪Bron, France
CHU Clermont Ferrand
馃嚝馃嚪Clermont Ferrand, France
AP-HM, H么pital La Timone
馃嚝馃嚪Marseille, France
CHU Toulouse
馃嚝馃嚪Toulouse, France
CHU tours
馃嚝馃嚪Tours, France
CHU Rouen
馃嚝馃嚪Rouen, France