Population Pharmacokinetics of Anti-infectious Drugs in Children
NCT ID: NCT01344512
Last Updated: 2015-03-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
214 participants
INTERVENTIONAL
2011-06-30
2014-09-30
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Patients treated with Ceftazidime
Ceftazidime
Bloods sampling on patient treated with Ceftazidime between 48 hours and 4 days after beginning of treatment.
Patients treated with Ciprofloxacin
Ciprofloxacin
Bloods sampling on patient treated with Ciprofloxacin between 48 hours and 4 days after beginning of treatment.
Patients treated with Voriconazole
Voriconazole
Bloods sampling on patient treated with Voriconazole between 48 hours and 4 days after beginning of treatment.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
28 Days
6 Years
ALL
No
Sponsors
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University Hospital, Bordeaux
OTHER
Responsible Party
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Principal Investigators
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Stéphanie Bui, Dr
Role: PRINCIPAL_INVESTIGATOR
University Hospital Bordeaux, France
Locations
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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
APHP - Hôpital NEcker
Paris, , France
AP-HP - Hôpital Robert Debré
Paris, , France
CHU Poitiers
Poitiers, , France
CHU Rouen
Rouen, , France
CHU Toulouse
Toulouse, , France
CHU tours
Tours, , France
Countries
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References
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Bui S, Facchin A, Ha P, Bouchet S, Leroux S, Nacka F, Fayon M, Jacqz-Aigrain E. Population pharmacokinetics of ceftazidime in critically ill children: impact of cystic fibrosis. J Antimicrob Chemother. 2020 Aug 1;75(8):2232-2239. doi: 10.1093/jac/dkaa170.
Other Identifiers
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CHUBX 2010/36
Identifier Type: -
Identifier Source: org_study_id
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