Dettagli per singolo studio

DEC-NET Serial number FR538

Published online	02/03/2006 22.33.00
Last updated	15/09/2006 16.03.40

Other protocol ID number	AO4090HS
Current trial status	Open (actively recruiting new participants)
Major Disease (ICD9 class)	UNSPECIFIED ADVERSE EFFECT OF DRUG MEDICINAL AND B
Experimental drug
All drugs Treatment regimen (dosage and duration)
Gender	Both
Age (range)	Children and Adult
Eligibility criteria
Inclusion criteria
-Children and adults presented adverse drug reaction -A control patient will be selected on the following criterias and matched with 1.patient with the same pathology,treatment without adverse reaction, age, ethnicity 2.patient with the same age, ethnicity but a different disease and treatment -Informed consent
Exclusion criteria
No informed consent
Trial design/methodology
Phase	4
Kind of study	Safety
Design
Purpose of study
-Obtain epidemiological data on the incidence and adverse reactions comparing adults and children -Investigate the risk factors for adverse drug reactions such as age, disease and associated therapy -With a focus on pharmacogenetic variations in drug metabolism (including enzymes, transporters and receptors) comparing patients with side effects and control patients
Primary outcomes
All major adverse reactions


Summary of study design, objectives, and ongoing research findings
The aims of this study are to investigate the risk factors including pharmacogenetic factors for major adverse drug reactions. All major adverse reactions occurring in patients in the hospitals participating to the network will be collected : -Either when notified spontaneously to the corresponding regional pharmacovigilance center participating in the network -Or when identified by prospective follow-up of the patients in selected adult or paediatric medical departments in the following subspecialties (Neurology / psychiatry, Hepato-gastro-enterology, Nephrology). In the event of a major adverse effect, the following steps are realized: -information and assent of the patients or his parents (if child) -database (demographic characters: age, disease, personal and familial past-history, family context,imputability and severity of the adverse effect (NICI classification), -Connected to a plasma bank and a DNA bank allowing pharmacogenomic studies, -For each drug, analysis of the metabolic profile, pharmacological data and possible implications of various polymorphisms and transporteurs in the occurrence of the observed adverse drug reaction.