Population Pharmacokinetics of Anti-infectious Drugs in Children (PHARMA-A)

University Hospital of Bordeaux

Status: Completed

Conditions: Voriconazole; Pediatrics; Ciprofloxacin; Ceftazidime

Treatments: Drug: Ceftazidime; Drug: Ciprofloxacin; Drug: Voriconazole

Study type: Interventional

Funder types: Other

Identifiers

NCT01344512

CHUBX 2010/36

Details and patient eligibility

About

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.

Full 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).

Enrollment: 214 patients

Sex: All

Ages: 28 days to 6 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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214 participants in 3 patient groups

Patients treated with Ceftazidime

Experimental group

Treatment:

Drug: Ceftazidime

Patients treated with Ciprofloxacin

Experimental group

Treatment:

Drug: Ciprofloxacin

Patients treated with Voriconazole

Experimental group

Treatment:

Drug: Voriconazole