ClinicalTrials.gg
RecruitingNCT04330118DRESSEOUpdated Apr 22, 2026

Origin and Function of Eosinophilic Polynuclear During DRESS Syndrome

An observational study in Drug Hypersensitivity and DRESS Syndrome, sponsored by University Hospital, Lille. Recruiting at 11 sites in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-22.

Sponsored by University Hospital, Lille · Observational

From the registry’s dates

  • Started Jul 2020; still recruiting 6 years 3 months later.
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
80
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Drug Hypersensitivity
  • DRESS Syndrome

Keywords

  • DRESS syndrome
  • Drug hypersensitivity
  • eosinophils
  • allergy
03

In context

Drug Hypersensitivity

57 studies on the registry are indexed under Drug Hypersensitivity; 18 are open to participants now.

This study's planned enrollment of 80 is below the median of 204 across 30 observational studies indexed under Drug Hypersensitivity.

Browse Drug Hypersensitivity studies →

Lead sponsor

University Hospital, Lille is the lead sponsor of 631 studies on the registry; 142 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Other cause of eosinophilia including cancer, blood disease before the introduction of suspected molecule(s).
  • On going oral or local 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.
  • related to the blood volume taken for the study.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
80 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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
06

What researchers measure

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

07

Study locations

11 of 11 sites recruiting
  • CH d'Arras
    Arras, France
    Recruiting
    • Céline DESVIGNES · Principal investigator
  • CH de Boulogne
    Boulogne-sur-Mer, France
    Recruiting
    • Sophie DARRAS · Principal investigator
  • Assistance Publique - Hôpitaux de Paris - HENRI MONDOR
    Créteil, France
    Recruiting
    • Olivier Chosidow · Principal investigator
  • CH de Douai
    Douai, France
    Recruiting
    • Eve DESMEDT · Principal investigator
  • CH de Dunkerque
    Dunkirk, France
    Recruiting
    • SOPHIE DUVERT-LEHEMBRE · Principal investigator
  • 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
    • PHILIPPE MODIANO · Principal investigator
  • CH de Roubaix
    Roubaix, France
    Recruiting
    • Olivier CARPENTIER · Principal investigator
  • Hôpital FOCH
    Suresnes, France
    Recruiting
    • Matthieu GROH · Principal investigator
  • CH de Valenciennes
    Valenciennes, France
    Recruiting
    • Marie WEINBORN · Principal investigator
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Jul 2020 (actual). Primary completion is estimated for Oct 2027, 87 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 30, 2020
First posted
Apr 1, 2020
StartActual
Jul 15, 2020
Primary completionEst.
Oct 2027
CompletionEst.
Oct 2027
Last update
Apr 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04330118
Collaborators
Société de Dermatologie Française, Société de Recherche en Dermatologie
Responsible party
Sponsor
First posted
Apr 1, 2020
Start date
Jul 15, 2020
Primary completion
Oct 2027 (estimated)
Completion
Oct 2027 (estimated)
Last update
Apr 22, 2026

Study contacts

Delphine Staumont-Salle, MD,PhD
Contact
delphine.salle@chru-lille.fr
0320444193 ext. +33
Delphine Staumont-Salle, MD,PhD
principal investigator · University Hospital, Lille

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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