Origin and Function of Eosinophilic Polynuclear During DRESS Syndrome

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Lille

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Cutaneous rash occurring at least 24 hours and at most 2 months after continuous medication use

Fever over 38 degre celcius

Lymphadenopathy

hepatitis

Disqualifiers

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.

Trial population

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

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

80 Participants
are grouped into 4 trial groups
Group A: 20 patients with DRESS syndrome
Group B: 20 patients with drug induced MPE with eosinophilia
Group C: 20 patients with drug induced MPE without eosinophilia
Group D: 20 Healthy subjects

Trial outcomes

Primary outcomes

1

Activation status of circulating eosinophils by flow cytometry

Time frame
Baseline

Secondary outcomes

1

Mean fluorescence intensity of CCR3 and IL-5R markers

Time frame
Baseline
2

Percentage of Th2 polarized T cells

Time frame
Baseline
3

Percentage of ILC2

Time frame
Baseline
4

Serum levels (ELISA) of inflammatory markers

Time frame
Baseline

Other outcomes

Sponsors and contacts

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University Hospital, Lille

Lead sponsor

Société de Dermatologie Française

Collaborator

Société de Recherche en Dermatologie

Collaborator