Clinical trial
A Randomized Controlled Pilot Trial of Cyclosporine vs Steroids in DRESS
Name
HS-20-00118
Description
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).
Trial arms
Trial start
2021-09-27
Estimated PCD
2025-04-30
Trial end
2025-06-30
Phase
Early phase I
Treatment
Cyclosporine
Patients randomized to cyclosporine will be treated as mentioned under "Arm/Group Description"
Arms:
Cyclosporine
Methylprednisolone and Prednisone
All patients randomized to steroids will initially be treated with IV methylprednisolone and eventually started on an oral prednisone taper.
Arms:
Corticosteroids
Size
50
Primary endpoint
Percentage of patients with complete or near complete resolution of organ involvement at day 30, on steroid therapy and cyclosporine therapy
Day 7
Percentage of patients with complete or near complete resolution of organ involvement at day 30, on steroid therapy and cyclosporine therapy
Day 30
Percentage of patients with complete or near complete resolution of erythema at day 7, on steroid therapy and cyclosporine therapy
Day 7
Percentage of patients with complete or near complete resolution of erythema at day 30, on steroid therapy and cyclosporine therapy
Day 30
Eligibility 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)
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}
Updated at
2023-11-30
1 organization
Organization
University of Southern California