Population Pharmacokinetics of Anti-infectious Drugs in Children

Study Overview
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Brief Summary
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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
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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).

Official Title
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Population Pharmacokinetics Of Ceftazidime, Ciprofloxacin And Voriconazole In Paediatric Young Patients (< 12 Years Old)

Conditions
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Pediatrics, Ceftazidime, Ciprofloxacin, Voriconazole

Intervention / Treatment
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* Drug: Ceftazidime
* Drug: Ciprofloxacin
* Drug: Voriconazole


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 28 Days
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients treated with Ceftazidime<br> | Drug: Ceftazidime<br>* Bloods sampling on patient treated with Ceftazidime between 48 hours and 4 days after beginning of treatment.<br>|
| Experimental: Patients treated with Ciprofloxacin<br> | Drug: Ciprofloxacin<br>* Bloods sampling on patient treated with Ciprofloxacin between 48 hours and 4 days after beginning of treatment.<br>|
| Experimental: Patients treated with Voriconazole<br> | Drug: Voriconazole<br>* Bloods sampling on patient treated with Voriconazole between 48 hours and 4 days after beginning of treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Population pharmacokinetic parameters and factors explaining variability | 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. | Between 2 and 4 days after the begining of the treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Covariability factors explaining the variability (age, biological data, pharmacokinetics factors, associated treatments...) |  | Between 2 and 4 days after the beginning of the treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacokinetic, Population, Children, Ceftazidime, Ciprofloxacin, Voriconazole, Pediatric