Status:
RECRUITING
Origin and Function of Eosinophilic Polynuclear During DRESS Syndrome
Lead Sponsor:
University Hospital, Lille
Collaborating Sponsors:
Société de Dermatologie Française
Société de Recherche en Dermatologie
Conditions:
Drug Hypersensitivity
DRESS Syndrome
Eligibility:
All Genders
18+ years
Brief Summary
Drug Hypersensitivity Syndrome or DRESS for "Drug Reaction with Eosinophilia and Systemic Symptoms" is a serious drug allergy which can be life-threatening for patients with serious organ damage. The ...
Eligibility Criteria
Inclusion
- Group 1 (DRESS): adult with a diagnosis of DRESS based on the following four criteria:
- Cutaneous rash occurring at least 24 hours and at most 2 months after continuous medication use
- Fever over 38 degre celcius
- At least one organ dysfunction among:
- Lymphadenopathy
- hepatitis
- Pulmonary involvement
- Cardiac involvement: myocarditis, pericarditis
- Renal impairment
- At least one of the following hematological anomalies:
- Eosinophilia ≥ 500 / mm3 .
- RegiSCAR Score ≥ 4
- Groups 2 and 3 (Drug induced maculopapular exanthema without or with eosinophilia).
- Adult with drug-induced rash
- Without clinical criteria of severity defined by Djien among :
- An evolution of more than 21 days
- with organ damage as defined in group 1
- Group 2 (MPE without eosinophilia): blood eosinophils \< 500 / mm3
- Group 3 (MPE with eosinophilia): blood eosinophils ≥ 500 / mm3
Exclusion
- Other cause of eosinophilia including cancer, blood disease before the introduction of suspected molecule(s).
- On going oral or local corticosteroid therapy, anti-leukotriene therapy (MONTELUKAST) by the month preceding the study;
- Anti-IgE therapy (OMALIZUMAB, LIGELIZUMAB), anti-IL-5 therapy (MEPOLIZUMAB, BENRALIZUMAB) or anti-IL4 and / or anti-IL13 therapy (DUPILUMAB, TRALOKINUMAB) in the 6 months preceding the study.
- Any pregnant or lactating woman.
- Contraindication related to the blood volume taken for the study.
Key Trial Info
Start Date :
July 15 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT04330118
Start Date
July 15 2020
End Date
October 1 2026
Last Update
December 23 2025
Active Locations (11)
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1
CH d'Arras
Arras, France
2
CH de Boulogne
Boulogne-sur-Mer, France
3
Assistance Publique - Hôpitaux de Paris - HENRI MONDOR
Créteil, France
4
CH de Douai
Douai, France