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NCT Number: NCT04330118

Origin and Function of Eosinophilic Polynuclear During DRESS Syndrome

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CH d'Arras, Arras, France

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

    Time frame: Baseline

  6. Density of extracellular granules (degranulation area and number / mm2) on skin biopsies

    Time frame: Baseline

  7. NGS analysis of rearrangements of TCR (T cell receptor)

    Time frame: Baseline and 3 months

Study contacts

Contact information is provided by the study sponsor or research team.

Delphine Staumont-Salle, MD,PhD

CONTACT

[email protected]

0320444193 ext. +33

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • Société de Dermatologie Française
  • Société de Recherche en Dermatologie

Registry information

Official study title

Origin and Function of Eosinophilic Polynuclear During Drug Reaction With Eosinophilia and Systemic Symptoms (DRESS) Syndrome

Acronym: DRESSEO

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Apr 1, 2020
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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