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

March 17, 2015 updated by: University Hospital, Bordeaux

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

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.

Study Overview

Status

Completed

Conditions

Intervention / 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).

Study Type

Interventional

Enrollment (Actual)

214

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33076
        • CHU de Bordeaux, Hôpital Pellegrin
      • Bron, France, 69500
        • Hospices Civils de Lyon
      • Clermont Ferrand, France, 63000
        • CHU Clermont Ferrand
      • Dijon, France, 21079
        • CHU de Dijon
      • Grenoble, France, 38043
        • Chu De Grenoble
      • Lille, France, 59037
        • CHRU Lille
      • Marseille, France, 13005
        • AP-HM, Hôpital La Timone
      • Montpellier, France, 34925
        • CHU Montpellier
      • Paris, France, 75015
        • APHP - Hopital Necker
      • Paris, France, 75019
        • AP-HP - Hôpital Robert Debré
      • Poitiers, France, 86000
        • CHU Poitiers
      • Rouen, France, 76031
        • CHU Rouen
      • Toulouse, France, 31059
        • CHU Toulouse
      • Tours, France, 37044
        • CHU Tours

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 weeks to 6 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Between 2 and 4 days after the begining of the treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Between 2 and 4 days after the beginning of the treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Investigators

  • Principal Investigator: Stéphanie Bui, Dr, University Hospital Bordeaux, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2011

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

April 27, 2011

First Submitted That Met QC Criteria

April 27, 2011

First Posted (Estimate)

April 29, 2011

Study Record Updates

Last Update Posted (Estimate)

March 18, 2015

Last Update Submitted That Met QC Criteria

March 17, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2010/36

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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