Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Clinical Trials in France / NCT04330118
Recruiting Observational

Origin and Function of Eosinophilic Polynuclear During DRESS Syndrome

NCT04330118 · tracked via the Priya Life Science France tracker
Sponsor
University Hospital, Lille
Phase
Observational
Started
2020-07-15
Last updated
2026-04-22

Condition(s) studied

Drug HypersensitivityDRESS Syndrome

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • Activation status of circulating eosinophils by flow cytometry — Baseline

Trial sites (11)

FacilityCityRegionStatus
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
Hop Claude Huriez Chr Lille Lille France Recruiting
Groupe Hospitalier de l'Institut Catholique de Lille Lille France Recruiting
CH de Roubaix Roubaix France Recruiting
Hôpital FOCH Suresnes France Recruiting
CH de Valenciennes Valenciennes France Recruiting

More University Hospital, Lille trials in France

Antibiotic Strategy and Asymptomatic Bacteriuria in the Context of Intra-vesical Botulinum Toxin A Injections. Starting soon
Individualized or Conventional Transfusion Strategies During Peripheral VA-ECMO Recruiting
Effectiveness of Erector Spinae Plane Block for Percutaneous Arthrodesis of Spinal Fractures Active, not recruiting
Performance of Carbon Dioxide (CO2)-Derived Parameters in Predicting Low Cardiac Output Syndrome Recruiting
Bone Marrow Fat and Bariatric Surgery-Mediated Bone Loss Recruiting

Other trials for the same condition

Interest of a Targeted Therapy for the Treatment of a Severe Form of Hypersensitivity to Drug (DRESS Syndrome) Starting soon
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04330118 on ClinicalTrials.gov ↗ ← All trials in France