Origin and Function of Eosinophilic Polynuclear During DRESS Syndrome

NCT04330118 | Recruiting

• 2 other identifiers: 2019_012019-A02026-51
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 11

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 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.

Conditions

Drug Hypersensitivity; DRESS Syndrome

Keywords

DRESS syndrome; Drug hypersensitivity; eosinophils; allergy

Outcome Measures

Primary Outcomes (1)

• Activation status of circulating eosinophils by flow cytometry

  Baseline

Secondary Outcomes (7)

• Mean fluorescence intensity of CCR3 and IL-5R markers

  Baseline

• Percentage of Th2 polarized T cells

  Baseline

• Percentage of ILC2

  Baseline

• Serum levels (ELISA) of inflammatory markers

  Baseline

• Correlation between the number of activated circulating eosinophils, area degranulation and severity of DRESS

  Baseline

Study Arms (4)

20 patients with DRESS syndrome

20 patients with drug induced MPE with eosinophilia

patients with drug induced maculopapular exanthema (MPE) with eosinophilia

20 patients with drug induced MPE without eosinophilia

20 Healthy subjects

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient with drug induced rash (DRESS, maculopapular exanthema) and healthy patients.

You may qualify if:

• 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 :

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Lille: lead
• Société de Dermatologie Française: collaborator
• Société de Recherche en Dermatologie: collaborator

Study Sites (11)

CH d'Arras

Arras, France

RECRUITING

CH de Boulogne

Boulogne-sur-Mer, France

RECRUITING

Assistance Publique - Hôpitaux de Paris - HENRI MONDOR

Créteil, France

RECRUITING

CH de Douai

Douai, France

RECRUITING

CH de Dunkerque

Dunkirk, France

RECRUITING

CH LENS

Lens, France

RECRUITING

Hop Claude Huriez Chr Lille

Lille, 59000, France

RECRUITING

Groupe Hospitalier de l'Institut Catholique de Lille

Lille, France

RECRUITING

CH de Roubaix

Roubaix, France

RECRUITING

Hôpital FOCH

Suresnes, France

RECRUITING

CH de Valenciennes

Valenciennes, France

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

* Blood sample * Serum * peripheral blood mononuclear cell * skin biopsy

MeSH Terms

Conditions

Drug Hypersensitivity; Drug Hypersensitivity Syndrome; Hypersensitivity

Condition Hierarchy (Ancestors)

Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Drug Eruptions; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Delayed; Immune System Diseases

Study Officials

• Delphine Staumont-Salle, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Delphine Staumont-Salle, MD,PhD

CONTACT

0320444193; delphine.salle@chru-lille.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2020
• First Posted: April 1, 2020
• Study Start: July 15, 2020
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-04

Locations

FR (11)