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Comparing Cyclosporine and Steroids for DRESS Syndrome

This study is comparing two standard treatments, cyclosporine and steroids (methylprednisolone and prednisone), for Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) Syndrome. DRESS is a potentially life-threatening allergic reaction to medication. We want to see which treatment works better to resolve organ involvement and skin rash. You might be able to join if you are an adult with a likely DRESS diagnosis and don't have certain conditions like active sepsis or severe kidney problems. The study aims to enroll 50 participants to help us understand the effectiveness and safety of these two treatments.

Study design
This is an interventional study comparing two standard treatments. It aims to enroll 50 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The study measures outcomes at Day 7 and Day 30, suggesting follow-up for at least 30 days.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04988256

Cyclosporine Vs Steroids in DRESS

Enrolling by Invitation
EARLY_PHASE1Ages 18+InterventionalTreatment
University of Southern California
~50 participants
Updated 2025-03-30 on ClinicalTrials.gov
What's tested:CyclosporineMethylprednisolone and Prednisone

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of patients with complete or near complete resolution of organ involvement at day 30, on steroid therapy and cyclosporine therapy
Measured over Day 7
+3 more outcomes measured

Conditions

DRESS Syndrome
Drug-Induced Hypersensitivity Syndrome

Explore related trials

Drug Hypersensitivity Syndrome

Where it's being run

1 sites across 1 states
California1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Adults with a RegiSCAR score of greater than 4 (i.e a likely diagnosis of DRESS)

Exclusion

Active sepsis
Active hepatitis B or C
Active tuberculosis
Documented allergy to steroids or cyclosporine
Estimated glomerular filtration rate (eGFR) \< 30 (unless on dialysis, in which case they will be included)

What this trial measures

  • Percentage of patients with complete or near complete resolution of organ involvement at day 30, on steroid therapy and cyclosporine therapyDay 7

    Measured by the following quantitative metrics: * Creatinine within 1.25x of baseline or upper limit of normal, whichever is higher * Aspartate Aminotransferase (AST) within 1.5x of baseline or upper limit of normal, whichever is higher * Troponin-T, Creatine Kinase Myocardial Band (CK-MB), Pro B-type Natriuretic Peptide (Pro-BNP), and lipase within 1.25x of baseline or upper limit of normal, whichever is higher * Resolution of interstitial pneumonitis on chest x-ray

  • Percentage of patients with complete or near complete resolution of organ involvement at day 30, on steroid therapy and cyclosporine therapyDay 30

    Measured by the following quantitative metrics: * Creatinine within 1.25x of baseline or upper limit of normal, whichever is higher * Aspartate Aminotransferase (AST) within 1.5x of baseline or upper limit of normal, whichever is higher * Troponin-T, Creatine Kinase Myocardial Band (CK-MB), Pro B-type Natriuretic Peptide (Pro-BNP), and lipase within 1.25x of baseline or upper limit of normal, whichever is higher * Resolution of interstitial pneumonitis on chest x-ray

  • Percentage of patients with complete or near complete resolution of erythema at day 7, on steroid therapy and cyclosporine therapyDay 7

    Clinical measurement of erythema

  • Percentage of patients with complete or near complete resolution of erythema at day 30, on steroid therapy and cyclosporine therapyDay 30

    Clinical measurement of erythema