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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-A02026-51 | Other Identifier | ID-RCB number,ANSM |
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| Name | Class |
|---|---|
| Société de Dermatologie Française | OTHER |
| Société de Recherche en Dermatologie | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Measure | Description | Time Frame |
|---|---|---|
| Activation status of circulating eosinophils by flow cytometry | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Mean fluorescence intensity of CCR3 and IL-5R markers | Baseline | |
| Percentage of Th2 polarized T cells | Baseline | |
| Percentage of ILC2 |
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Inclusion Criteria:
Group 1 (DRESS): adult with a diagnosis of DRESS based on the following four criteria:
Groups 2 and 3 (Drug induced maculopapular exanthema without or with eosinophilia).
Group 2 (MPE without eosinophilia): blood eosinophils < 500 / mm3
Group 3 (MPE with eosinophilia): blood eosinophils ≥ 500 / mm3
Exclusion Criteria:
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Patient with drug induced rash (DRESS, maculopapular exanthema) and healthy patients.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Delphine Staumont-Salle, MD,PhD | Contact | 0320444193 | +33 | delphine.salle@chru-lille.fr |
| Name | Affiliation | Role |
|---|---|---|
| Delphine Staumont-Salle, MD,PhD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CH d'Arras | Recruiting | Arras | France |
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| ID | Term |
|---|---|
| D004342 | Drug Hypersensitivity |
| D063926 | Drug Hypersensitivity Syndrome |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D003875 | Drug Eruptions |
| D003872 | Dermatitis |
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| Baseline |
| Serum levels (ELISA) of inflammatory markers | Baseline |
| Correlation between the number of activated circulating eosinophils, area degranulation and severity of DRESS | Baseline |
| Density of extracellular granules (degranulation area and number / mm2) on skin biopsies | Baseline |
| NGS analysis of rearrangements of TCR (T cell receptor) | Baseline and 3 months |
| CH de Boulogne | Recruiting | Boulogne-sur-Mer | France |
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| Assistance Publique - Hôpitaux de Paris - HENRI MONDOR | Recruiting | Créteil | France |
|
| CH de Douai | Recruiting | Douai | France |
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| CH de Dunkerque | Recruiting | Dunkirk | France |
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| CH LENS | Recruiting | Lens | France |
| Hop Claude Huriez Chr Lille | Recruiting | Lille | 59000 | France |
| Groupe Hospitalier de l'Institut Catholique de Lille | Recruiting | Lille | France |
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| CH de Roubaix | Recruiting | Roubaix | France |
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| Hôpital FOCH | Recruiting | Suresnes | France |
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| CH de Valenciennes | Recruiting | Valenciennes | France |
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| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006968 | Hypersensitivity, Delayed |
| D007154 | Immune System Diseases |