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Immunosuppressant

Cyclosporine vs Steroids for DRESS Syndrome

Phase < 1

Waitlist Available

Research Sponsored by University of Southern California

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Active tuberculosis

Active sepsis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0-120 days

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare outcomes of DRESS between two standard therapies, steroids and cyclosporine.

Who is the study for?

Adults with a likely diagnosis of DRESS (a severe skin reaction to drugs) as indicated by a RegiSCAR score over 4 can join this trial. It's not for those who have allergies to steroids or cyclosporine, active hepatitis B/C, sepsis, tuberculosis, or severely reduced kidney function unless they're on dialysis.

What is being tested?

The study compares two standard treatments for DRESS: Cyclosporine versus Steroids (Methylprednisolone and Prednisone). This pilot RCT aims to determine which treatment is more effective without additional procedures beyond routine care.

What are the potential side effects?

Possible side effects from Cyclosporine include kidney problems and high blood pressure. Steroids may cause weight gain, bone loss, high blood sugar levels among other potential issues.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have active tuberculosis.

Select...

I am currently suffering from a severe infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0-120 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0-120 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-120 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

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

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

Secondary study objectives

30-day readmission rate

Absolute eosinophil proportion compared to peak value

Mortality

+7 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: CorticosteroidsExperimental Treatment1 Intervention

All Patients start with 500 mg IV Methylprednisolone for 3 days 1. If \>25% improvement (must be \>25% in all involved organs), start the taper regimen 2. If 0-25% improvement (in ≥1 involved internal organ), give 500 mg IV Methylprednisolone for 4 days 1. If no improvement, switch to cyclosporine arm of treatment 2. If 0-25% improvement, give 500 mg IV Methylprednisolone for 3 days i. If labs are down-trending, start the taper regimen ii. If labs are not down-trending, switch to cyclosporine arm of the study c. If \>25% improvement, start the taper regimen Taper Regimen set as: 1. 125 mg IV Methylprednisolone x3 days 2. 1.2 mg/kg PO prednisone x1 week 3. 1 mg/kg PO prednisone x1 week 4. 0.8 mg/kg PO prednisone x1 week 5. 0.6 mg/kg PO prednisone x1 week 6. 0.4 mg/kg PO prednisone x1 week 7. 0.2 mg/kg PO prednisone x1 week 8. 0.1 mg/kg PO prednisone x1 week 9. 0.05 mg/kg PO prednisone x1 week

Group II: CyclosporineActive Control1 Intervention

All Patients start with 5 mg/kg/day (3 mg/kg/day if renal impairment) PO divided bid for 7 days (or IV if patient is NPO) 1. If complete resolution, stop cyclosporine and monitor closely for relapse a. If patient relapses, give 5 (3 if renal impairment) mg/kg/day PO divided bid PO for 7 days i. If down-trending, start oral taper regimen ii. If not down-trending, switch to steroid arm 2. If \>25% improvement and labs are down-trending, start the oral taper regimen. 3. If 0-25% improvement, give 5 (3 if renal impairment) mg/kg/day PO divided bid for 3 days 1. If down-trending, start oral taper regimen 2. If not down-trending, switch to steroid arm 4. If no improvement or up-trending labs at 7 days, switch to steroid arm Oral Taper Regimen set as 3 mg/kg PO divided bid for 14 days, then 2 mg/kg PO divided bid for 20 days. If renal impairment, oral taper regimen set as 2 mg/kg PO divided bid for 14 days, then 1 mg/kg PO divided bid for 20 days

0 / 2Eligibility criteria met