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Scientists investigate key immune cells in severe drug allergy

NCT ID NCT04330118

Knowledge-focused Sponsor: University Hospital, Lille Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study aims to understand how a type of white blood cell called eosinophils contributes to DRESS syndrome, a severe and potentially life-threatening drug allergy. Researchers will compare blood and skin samples from 80 adults with DRESS, other drug rashes, and healthy volunteers. The goal is to find better ways to diagnose and treat this condition in the future.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2020

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

allergic disease drug allergy drug rash with eosinophilia and systemic symptoms

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Dress syndrome Drug hypersensitivity

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    11 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Assistance Publique - Hôpitaux de Paris - HENRI MONDOR

    RECRUITING

    Créteil, France

  • CH LENS

    RECRUITING

    Lens, France

  • CH d'Arras

    RECRUITING

    Arras, France

  • CH de Boulogne

    RECRUITING

    Boulogne-sur-Mer, France

  • CH de Douai

    RECRUITING

    Douai, France

  • CH de Dunkerque

    RECRUITING

    Dunkirk, France

  • CH de Roubaix

    RECRUITING

    Roubaix, France

  • CH de Valenciennes

    RECRUITING

    Valenciennes, France

  • Groupe Hospitalier de l'Institut Catholique de Lille

    RECRUITING

    Lille, France

  • Hop Claude Huriez Chr Lille

    RECRUITING

    Lille, 59000, France

  • Hôpital FOCH

    RECRUITING

    Suresnes, France

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