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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
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 moreAwards & 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
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Who is running the clinical trial?
University of Southern CaliforniaLead Sponsor
946 Previous Clinical Trials
1,604,773 Total Patients Enrolled