Population Pharmacokinetics of Anti-infectious Drugs in Children

Pediatrics Clinical Trial

— PHARMA-A  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01344512
• Other study ID #: CHUBX 2010/36
• Status: Completed
• Phase: N/A
• First received: April 27, 2011
• Last updated: March 17, 2015
• Start date: June 2011
• Est. completion date: September 2014

Study information

• Verified date: March 2015
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 214
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 6 Years

Eligibility

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:

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Ceftazidime
• Ciprofloxacin
• Pediatrics
• Voriconazole

Intervention

Drug:
• Ceftazidime
Bloods sampling on patient treated with Ceftazidime between 48 hours and 4 days after beginning of treatment.
• Ciprofloxacin
Bloods sampling on patient treated with Ciprofloxacin between 48 hours and 4 days after beginning of treatment.
• Voriconazole
Bloods sampling on patient treated with Voriconazole between 48 hours and 4 days after beginning of treatment.

Locations

Country	Name	City	State
France	CHU de Bordeaux, Hôpital Pellegrin	Bordeaux
France	Hospices Civils de Lyon	Bron
France	CHU Clermont Ferrand	Clermont Ferrand
France	CHU de Dijon	Dijon
France	CHU de Grenoble	Grenoble
France	CHRU Lille	Lille
France	AP-HM, Hôpital La Timone	Marseille
France	CHU Montpellier	Montpellier
France	AP-HP - Hôpital Robert Debré	Paris
France	APHP - Hôpital NEcker	Paris
France	CHU Poitiers	Poitiers
France	CHU Rouen	Rouen
France	CHU Toulouse	Toulouse
France	CHU tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Covariability factors explaining the variability (age, biological data, pharmacokinetics factors, associated treatments...)		Between 2 and 4 days after the beginning of the treatment	No