Drug Hypersensitivity Syndrome, Epilepsy
Conditions
Brief summary
A recent study has shown that certain drug allergies were actually related to an immune system against certain viruses. The aim of the study is to evaluate, in patients taking antiepileptic drugs, if this treatment induces proliferation of these viruses and secondarily an immune response that would promote the development of a rash. In particular, will be studied whether these drugs can induce virus reactivation dormant in the immune system. This study will not affect the usual follow-up proposed by investigators, with the exception of some additional blood samples.
Interventions
DRUGanti-epileptic drug
Patient who initiate anti-epileptic drug (sodium valproate, divalproate sodium, valpromide, lamotrigine, carbamazepine, oxcarbazepine, eslicarbazepine acetate)
BIOLOGICALBlood sampling
Blood sampling is done for Patient who initiate anti-epileptic drug (sodium valproate, divalproate sodium, valpromide, lamotrigine, carbamazepine, oxcarbazepine, eslicarbazepine acetate)
Sponsors
University Hospital, Rouen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients age over 18 years * Patient for whom treatment of antiepileptic class will be started or was set for less than 48 hours and including one of the following molecules (as princeps or generic equivalent form): sodium valproate, divalproate sodium, valpromide, lamotrigine, carbamazepine, oxcarbazepine eslicarbazepine acetate. * Patient or patient's representative who was informed and signed the consent form * Effective contraception in women of childbearing age * Affiliation to health insurance
Exclusion criteria
* Immunosuppressive therapy in progress or acquired immunodeficiency * Patient with meningitis or meningoencephalitis * Patient with known contraindications to any molecules indicated in the study * Major Patient protection (guardianship) or deprived of liberty by judicial or administrative decision. * Patient participating in another clinical trial or participated in another trial in the month before. * Pregnant or breastfeeding women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients with viral reactivation of Epstein-Barr Virus | 3 Months | Number of patients with viral reactivation of Epstein-Barr Virus is evaluated in patients initiating an anti-epileptic treatment |
| Number of patients with viral reactivation of Human Herpes Virus 6 | 3 Months | Number of patients with viral reactivation of Human Herpes Virus 6 is evaluated in patients initiating an anti-epileptic treatment |
| Number of patients with viral reactivation of Human Herpes Virus 7 | 3 Months | Number of patients with viral reactivation of Human Herpes Virus 7 is evaluated in patients initiating an anti-epileptic treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in lymphocyte population count | 3 Months | Lymphocyte population count will be compared between baseline and 3 months after the treatment initiation |
Countries
France
Outcome results
None listed