Drug HypersensitivityDRESSEONCT04330118
Origin and Function of Eosinophilic Polynuclear During DRESS Syndrome
An observational study of Drug Hypersensitivity and DRESS Syndrome, run by University Hospital, Lille at 11 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Drug Hypersensitivity, DRESS Syndrome
- How many people
- 80 participants
- Where
- 11 sitesFrance
- Study dates
- 15 Jul 2020to Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patient with drug induced rash (DRESS, maculopapular exanthema) and healthy patients.
Who may be able to join
- 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
Show all 19Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
France11 sites, 11 recruiting
- Recruiting
CH d'Arras
Arras
Céline DESVIGNES
- Recruiting
CH de Boulogne
Boulogne-sur-Mer
Sophie DARRAS
- Recruiting
Assistance Publique - Hôpitaux de Paris - HENRI MONDOR
Créteil
Olivier Chosidow
- Recruiting
CH de Douai
Douai
Eve DESMEDT
- Recruiting
CH de Dunkerque
Dunkirk
SOPHIE DUVERT-LEHEMBRE
- Recruiting
CH LENS
Lens
- Recruiting
Hop Claude Huriez Chr Lille
Lille, 59000
- Recruiting
Groupe Hospitalier de l'Institut Catholique de Lille
Lille
PHILIPPE MODIANO
- Recruiting
CH de Roubaix
Roubaix
Olivier CARPENTIER
- Recruiting
Hôpital FOCH
Suresnes
Matthieu GROH
- Recruiting
CH de Valenciennes
Valenciennes
Marie WEINBORN
About this study
Official title: Origin and Function of Eosinophilic Polynuclear During Drug Reaction With Eosinophilia and Systemic Symptoms (DRESS) Syndrome
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.
- Conditions
- Drug Hypersensitivity, DRESS Syndrome
- Keywords
- DRESS syndrome, Drug hypersensitivity, eosinophils, allergy
- Medical subject headings
- Drug Hypersensitivity, Drug Hypersensitivity Syndrome, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 20 patients with DRESS syndrome | Not described | |
| 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 | Not described | |
| 20 Healthy subjects | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Activation status of circulating eosinophils by flow cytometry
Measured: Baseline
Secondary outcomes (7)
Mean fluorescence intensity of CCR3 and IL-5R markers
Measured: Baseline
Percentage of Th2 polarized T cells
Measured: Baseline
Percentage of ILC2
Measured: Baseline
Serum levels (ELISA) of inflammatory markers
Measured: Baseline
Correlation between the number of activated circulating eosinophils, area degranulation and severity of DRESS
Measured: Baseline
Density of extracellular granules (degranulation area and number / mm2) on skin biopsies
Measured: Baseline
NGS analysis of rearrangements of TCR (T cell receptor)
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2020
- Study start15 Jul 2020
- Primary completionOct 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug HypersensitivityStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Collaborators
- Société de Dermatologie Française, Société de Recherche en Dermatologie
- Responsible party
- Sponsor
- Investigators
- Delphine Staumont-Salle, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04330118
- Sponsor's protocol ID
- 2019_01
- Other IDs
- 2019-A02026-51
- Acronym
- DRESSEO
- Status last verified
- Apr 2026
- First submitted
- 30 Mar 2020
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Origin and Function of Eosinophilic Polynuclear During Drug Reaction With Eosinophilia and Systemic Symptoms (DRESS) Syndrome
- ClinicalTrials.gov ID
- NCT04330118
- Acronym / sponsor ID
- DRESSEO / 2019_01
- Conditions
- Drug Hypersensitivity, DRESS Syndrome
- Keywords
- DRESS syndrome, Drug hypersensitivity, eosinophils, allergy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Collaborators
- Société de Dermatologie Française, Société de Recherche en Dermatologie
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 1 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with drug induced rash (DRESS, maculopapular exanthema) and healthy patients.
Key inclusion criteria (19 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Activation status of circulating eosinophils by flow cytometry
Time frame: Baseline
7 secondary outcomes
Mean fluorescence intensity of CCR3 and IL-5R markers
Time frame: Baseline
Percentage of Th2 polarized T cells
Time frame: Baseline
Percentage of ILC2
Time frame: Baseline
Serum levels (ELISA) of inflammatory markers
Time frame: Baseline
Correlation between the number of activated circulating eosinophils, area degranulation and severity of DRESS
Time frame: Baseline
Density of extracellular granules (degranulation area and number / mm2) on skin biopsies
Time frame: Baseline
NGS analysis of rearrangements of TCR (T cell receptor)
Time frame: Baseline and 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Delphine Staumont-Salle, MD,PhD principal investigator
University Hospital, Lille
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Drug Hypersensitivity and DRESS Syndrome, run by University Hospital, Lille at 11 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Delphine Staumont-Salle, MD,PhD (0320444193 ext. +33, delphine.salle@chru-lille.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Activation status of circulating eosinophils by flow cytometry (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.