Overview

Cyclosporine vs Steroids in DRESS

Status:
Enrolling by invitation
Trial end date:
2023-06-30
Target enrollment:
0
Participant gender:
All
Summary
Current treatments for patients with drug reaction with eosinophilia and systemic symptoms (DRESS) include supportive care, steroids and cyclosporine. No randomized controlled trial (RCT) exists in comparing these treatments and all available literature comes in the form of case reports and case series. These two treatments are considered standard of care and this trial seeks only to compare outcomes of DRESS between these two therapies. No additional labs, therapies or procedures will be used apart from those that are routinely done for patients with this diagnosis. This will be a pilot study to determine efficacy of the two therapies with particular endpoints in mind so that the investigators can study the safety of these two therapies in patients with DRESS. Data suggests a potential benefit for adults with DRESS using either steroids or cyclosporine but the investigators are seeking a comparison of efficacy of these two therapies. The study population will include adults with a Registry of Severe Cutaneous Adverse Reaction (RegiSCAR) score of greater than 4 (i.e. a likely diagnosis of DRESS). The investigators will exclude patients with sepsis, active Hepatitis B or C, active tuberculosis, a documented allergy to steroids or cyclosporine, and patients with an estimated glomerular filtration rate (eGFR) < 30 (unless on dialysis in which case the participants will be included).
Phase:
Early Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University of Southern California
Treatments:
Cyclosporine
Cyclosporins
Methylprednisolone
Prednisone
Criteria
Inclusion Criteria:

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

Exclusion Criteria:

- 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)