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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01344512
First Posted: April 29, 2011
Last Update Posted: March 18, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Bordeaux
  Purpose
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.

Condition Intervention
Pediatrics Ceftazidime Ciprofloxacin Voriconazole Drug: Ceftazidime Drug: Ciprofloxacin Drug: Voriconazole

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Population Pharmacokinetics Of Ceftazidime, Ciprofloxacin And Voriconazole In Paediatric Young Patients (< 12 Years Old)

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • Population pharmacokinetic parameters and factors explaining variability [ Time Frame: 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:
  • 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 ]

Enrollment: 214
Study Start Date: June 2011
Study Completion Date: September 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patients treated with Ceftazidime Drug: Ceftazidime
Bloods sampling on patient treated with Ceftazidime between 48 hours and 4 days after beginning of treatment.
Experimental: Patients treated with Ciprofloxacin Drug: Ciprofloxacin
Bloods sampling on patient treated with Ciprofloxacin between 48 hours and 4 days after beginning of treatment.
Experimental: Patients treated with Voriconazole Drug: Voriconazole
Bloods sampling on patient treated with Voriconazole between 48 hours and 4 days after beginning of treatment.

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).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01344512


Locations
France
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
CHRU Lille
Lille, France, 59037
AP-HM, Hôpital La Timone
Marseille, France, 13005
CHU Montpellier
Montpellier, France, 34925
APHP - Hôpital NEcker
Paris, France, 75015
AP-HP - Hôpital Robert Debré
Paris, France, 75019
CHU Poitiers
Poitiers, France, 86000
CHU Rouen
Rouen, France, 76031
CHU Toulouse
Toulouse, France, 31059
CHU tours
Tours, France, 37044
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Principal Investigator: Stéphanie Bui, Dr University Hospital Bordeaux, France
  More Information

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT01344512     History of Changes
Other Study ID Numbers: CHUBX 2010/36
First Submitted: April 27, 2011
First Posted: April 29, 2011
Last Update Posted: March 18, 2015
Last Verified: March 2015

Keywords provided by University Hospital, Bordeaux:
Pharmacokinetic
Population
Children
Ceftazidime
Ciprofloxacin
Voriconazole
Pediatric

Additional relevant MeSH terms:
Ciprofloxacin
Ceftazidime
Voriconazole
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Antifungal Agents
14-alpha Demethylase Inhibitors
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP3A Inhibitors