Population Pharmacokinetics of Anti-infectious Drugs in Children (PHARMA-A)
|Study Design:||Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Population Pharmacokinetics Of Ceftazidime, Ciprofloxacin And Voriconazole In Paediatric Young Patients (< 12 Years Old)|
- Population pharmacokinetic parameters and factors explaining variability [ Time Frame: Between 2 and 4 days after the begining of the treatment ] [ Designated as safety issue: No ]
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.
- Covariability factors explaining the variability (age, biological data, pharmacokinetics factors, associated treatments...) [ Time Frame: Between 2 and 4 days after the beginning of the treatment ] [ Designated as safety issue: No ]
|Study Start Date:||June 2011|
|Study Completion Date:||September 2014|
|Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
|Experimental: Patients treated with Ceftazidime||
Bloods sampling on patient treated with Ceftazidime between 48 hours and 4 days after beginning of treatment.
|Experimental: Patients treated with Ciprofloxacin||
Bloods sampling on patient treated with Ciprofloxacin between 48 hours and 4 days after beginning of treatment.
|Experimental: Patients treated with Voriconazole||
Bloods sampling on patient treated with Voriconazole between 48 hours and 4 days after beginning of treatment.
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01344512
|CHU de Bordeaux, Hôpital Pellegrin|
|Bordeaux, France, 33076|
|Hospices Civils de Lyon|
|Bron, France, 69500|
|CHU Clermont Ferrand|
|Clermont Ferrand, France, 63000|
|CHU de Dijon|
|Dijon, France, 21079|
|CHU de Grenoble|
|Grenoble, France, 38043|
|Lille, France, 59037|
|AP-HM, Hôpital La Timone|
|Marseille, France, 13005|
|Montpellier, France, 34925|
|APHP - Hôpital NEcker|
|Paris, France, 75015|
|AP-HP - Hôpital Robert Debré|
|Paris, France, 75019|
|Poitiers, France, 86000|
|Rouen, France, 76031|
|Toulouse, France, 31059|
|Tours, France, 37044|
|Principal Investigator:||Stéphanie Bui, Dr||University Hospital Bordeaux, France|