Where eosinophils come from and what they do in DRESS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational project enrolls adults with DRESS and two comparison groups of adults with drug-induced maculopapular exanthema (with and without blood eosinophilia). Investigators will collect blood and tissue samples to characterize eosinophil origin, surface activation markers, T-cell polarization, and potential involvement of type 2 innate lymphoid cells (ILC2). They will correlate tissue eosinophil infiltration and activation with organ involvement and clinical severity to identify distinct endotypes. Recruitment and sample collection take place at participating hospitals in France for laboratory and immunologic analyses.

Why it matters

Who can join: the full rules

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.

Where it's running

• 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

Study contacts

• Principal investigator: Delphine Staumont-Salle, MD,PhD — University Hospital, Lille
• Study coordinator: Delphine Staumont-Salle, MD,PhD
• Email: delphine.salle@chru-lille.fr
• Phone: 0320444193

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.