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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University Hospital, Bordeaux
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT01344512
First received: April 27, 2011
Last updated: January 31, 2014
Last verified: January 2014
  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
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)

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 ] [ 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.



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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 350
Study Start Date: June 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 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

Ages Eligible for Study:   up to 6 Years
Genders Eligible for Study:   Both
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:

Not Applicable

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01344512

Contacts
Contact: Stéphanie Bui, Dr (33) 5 56 79 87 37 stephanie.bui@chu-bordeaux.fr
Contact: Michael Fayon, Pr (33) 5 56 79 98 24 Michael.fayon@chu-boredeaux.fr

Locations
France
CHU de Bordeaux, Hôpital Pellegrin Recruiting
Bordeaux, France, 33076
Contact: Stéphanie BUI, Dr    (33) 5 56 79 87 37    stephanie.bui@chu-bordeaux.fr   
Principal Investigator: Stéphanie BUI, Dr         
Sub-Investigator: Michael FAYON, Pr         
Sub-Investigator: Cécile VERITE, Dr         
Sub-Investigator: Paul NOLENT, Dr         
Hospices Civils de Lyon Recruiting
Bron, France, 69500
Contact: Yves BERTRAND, Pr       yves.bertrand@chu-lyon.fr   
Principal Investigator: Yves BERTRAND, Pr         
CHU Clermont Ferrand Recruiting
Clermont Ferrand, France, 63000
Contact: François Demeocq, Pr       fdemeocq@chu-clermontferrand.fr   
Principal Investigator: François Demeocq, Pr         
CHU de Dijon Recruiting
Dijon, France, 21079
Contact: Marc BARDOU       marc.Bardou@u-bourgogne.fr   
Principal Investigator: Marc BARDOU, Pr         
Sub-Investigator: Frédéric HUET, Pr         
CHU de Grenoble Recruiting
Grenoble, France, 38043
Contact: Isabelle PIN, Dr         
Principal Investigator: Isabelle PIN, Dr         
CHRU Lille Recruiting
Lille, France, 59037
Contact: Frédéric Gottrand, Pr         
Principal Investigator: Frédéric GOTTRAND, Pr         
AP-HM, Hôpital La Timone Recruiting
Marseille, France, 13005
Contact: Michel Tsimaratos, Pr         
Principal Investigator: Michel Tsimaratos, Pr         
CHU Montpellier Recruiting
Montpellier, France, 34925
Contact: Gilles Cambonie, Pr       g-cambonie@chu-montpellier.fr   
Principal Investigator: Gilles CAMBONIE, Pr         
APHP - Hôpital NEcker Recruiting
Paris, France, 75015
Contact: Jean-Marc Treluyer, Pr         
Principal Investigator: Jean-Marc Treluyer, Pr         
AP-HP - Hôpital Robert Debré Recruiting
Paris, France, 75019
Contact: Evelyne Jacz-Aigrain, Pr       evelyne.jacqzaigrain@gmail.com   
Principal Investigator: Evelyne Jacz-Aigrain, Pr         
CHU Poitiers Recruiting
Poitiers, France, 86000
Contact: Régis Hankard, Dr       r.hankard@chu-poitiers.fr   
Principal Investigator: Régis HANKARD, Dr         
CHU Rouen Recruiting
Rouen, France, 76031
Contact: Eric MALLET       eric.mallet@chu-rouen.fr   
Principal Investigator: Eric MALLET, Pr         
CHU Toulouse Recruiting
Toulouse, France, 31059
Contact: Jean-Pierre SALLES, Pr       salle.jp@chu-toulouse.fr   
Principal Investigator: Jean-Pierre SALLES, Pr         
CHU tours Recruiting
Tours, France, 37044
Contact: François Labarthe       labarthe@med.univ-tours.fr   
Principal Investigator: François LABARTHE, Pr         
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Principal Investigator: Stéphanie Bui, Dr University Hospital Bordeaux, France
  More Information

No publications provided

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT01344512     History of Changes
Other Study ID Numbers: CHUBX 2010/36
Study First Received: April 27, 2011
Last Updated: January 31, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Ceftazidime
Voriconazole
Ciprofloxacin
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antifungal Agents
14-alpha Demethylase Inhibitors

ClinicalTrials.gov processed this record on July 23, 2014