Origin and Function of Eosinophilic Polynuclear During DRESS Syndrome (NCT04330118) | Clinical Trial Compass
RecruitingNot Applicable
Origin and Function of Eosinophilic Polynuclear During DRESS Syndrome
France80 participantsStarted 2020-07-15
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Activation status of circulating eosinophils by flow cytometry