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Origin and Function of Eosinophilic Polynuclear During DRESS Syndrome

NCT ID: NCT04330118

Last Updated: 2025-12-23

Study Results

Results pending

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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Recruitment Status

RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-15

Study Completion Date

2026-10-31

Brief Summary

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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 pathophysiology of DRESS is still not fully understood. In particular, no study has focused on the characterization of eosinophils, while paradoxically eosinophilia is one of the diagnostic criteria. Likewise, there is no data about the origin of eosinophils and few data are available concerning immune polarization of T-cells or the involvement of innate lymphoid cells type 2 in the recruitment of eosinophils. Our preliminary data on increase activation markers membrane expression of cutaneous eosinophils suggest that this approach could allow the identification of endotypes in which eosinophils are involved and contribute to organ damages. The correlation between tissue infiltration of eosinophils and their degree of activation would then justify the development of targeted therapeutic strategies in DRESS syndrome (anti-IL-5 therapy?). The aim of the project is: 1) Evaluate the activation status of circulating and cutaneous eosinophils in patients with DRESS compared with drug induced maculopapular exanthema without or with eosinophilia (but do not fulfill DRESS criteria) and healthy subjects; 2) Understand the pathophysiological mechanisms at the origin of this eosinophilia.

Detailed Description

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Conditions

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Drug Hypersensitivity DRESS Syndrome

Keywords

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DRESS syndrome Drug hypersensitivity eosinophils allergy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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20 patients with DRESS syndrome

No interventions assigned to this group

20 patients with drug induced MPE with eosinophilia

patients with drug induced maculopapular exanthema (MPE) with eosinophilia

No interventions assigned to this group

20 patients with drug induced MPE without eosinophilia

No interventions assigned to this group

20 Healthy subjects

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

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 Criteria

* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Société de Dermatologie Française

OTHER

Sponsor Role collaborator

Société de Recherche en Dermatologie

UNKNOWN

Sponsor Role collaborator

University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Delphine Staumont-Salle, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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CH d'Arras

Arras, , France

Site Status RECRUITING

CH de Boulogne

Boulogne-sur-Mer, , France

Site Status RECRUITING

Assistance Publique - Hôpitaux de Paris - HENRI MONDOR

Créteil, , France

Site Status RECRUITING

CH de Douai

Douai, , France

Site Status RECRUITING

CH de Dunkerque

Dunkirk, , France

Site Status RECRUITING

CH LENS

Lens, , France

Site Status RECRUITING

Hop Claude Huriez Chr Lille

Lille, , France

Site Status RECRUITING

Groupe Hospitalier de l'Institut Catholique de Lille

Lille, , France

Site Status RECRUITING

CH de Roubaix

Roubaix, , France

Site Status RECRUITING

Hôpital FOCH

Suresnes, , France

Site Status RECRUITING

CH de Valenciennes

Valenciennes, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Delphine Staumont-Salle, MD,PhD

Role: CONTACT

Phone: 0320444193

Email: [email protected]

Other Identifiers

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2019-A02026-51

Identifier Type: OTHER

Identifier Source: secondary_id

2019_01

Identifier Type: -

Identifier Source: org_study_id