Clinical trial NCT04988256: Cyclosporine Vs Steroids in DRESS
Official title: A Randomized Controlled Pilot Trial of Cyclosporine Vs Steroids in DRESS
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: EARLY_PHASE1
Conditions: DRESS Syndrome
Drug-Induced Hypersensitivity Syndrome
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2021-08-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed description: Current treatments for patients with drug reaction with eosinophilia and systemic symptoms (DRESS) include supportive care, steroids, cyclosporine and to a lesser extent, intravenous immunoglobulin (IVIG). Regarding IVIG, a recent case series suggests no improved benefit in adults. 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. Hopefully, this study will allow the investigators to better power a full prospective trial in the future.

This is a potentially life-threatening severe cutaneous adverse reaction (SCAR) with significant potential morbidity. 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).

Participants will be randomized using a randomization protocol at all sites. Primary endpoints will include percentage of participants with complete or near complete resolution of organ involvement as well as erythema resolution at day 7 and day 30.

Secondary endpoints will be:

1. fever presence, resolution of facial edema, resolution of pruritus, lymphadenopathy, eosinophil count at days 7 and 30
2. days of hospitalization
3. mortality at days 7, 30 and 90
4. viral reactivation at days 30, 60 and 90
5. those with autoimmune development by day 30 and day 90
6. 30 day re-admission rate.

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)

Primary outcomes:
measure: Percentage of patients with complete or near complete resolution of organ involvement at day 30, on steroid therapy and cyclosporine therapy
timeFrame: Day 7
measure: Percentage of patients with complete or near complete resolution of organ involvement at day 30, on steroid therapy and cyclosporine therapy
timeFrame: Day 30
measure: Percentage of patients with complete or near complete resolution of erythema at day 7, on steroid therapy and cyclosporine therapy
timeFrame: Day 7
measure: Percentage of patients with complete or near complete resolution of erythema at day 30, on steroid therapy and cyclosporine therapy
timeFrame: Day 30
Secondary outcomes:
measure: Percentage of patients with resolution of fever
timeFrame: Day 7
measure: Percentage of patients with resolution of fever
timeFrame: Day 30
measure: Percentage of patients with resolution of facial edema
timeFrame: Day 7
measure: Percentage of patients with resolution of facial edema
timeFrame: Day 30
measure: Percentage of patients with resolution of pruritus
timeFrame: Day 7
measure: Percentage of patients with resolution of pruritus
timeFrame: Day 30
measure: Percentage of patients with resolution of lymphadenopathy
timeFrame: Day 7
measure: Percentage of patients with resolution of lymphadenopathy
timeFrame: Day 30
measure: Absolute eosinophil proportion compared to peak value
timeFrame: Day 7
measure: Absolute eosinophil proportion compared to peak value
timeFrame: Day 30
measure: Patients with autoimmune disease development
timeFrame: Day 30
measure: Patients with autoimmune disease development
timeFrame: Day 90
measure: Total days of hospitalization after initial dermatology consult
timeFrame: 0-120 days
measure: Viral reactivation
timeFrame: Day 30
measure: Viral reactivation
timeFrame: Day 60
measure: Viral reactivation
timeFrame: Day 90
measure: Mortality
timeFrame: Day 7
measure: Mortality
timeFrame: Day 30
measure: Mortality
timeFrame: Day 90
measure: 30-day readmission rate
timeFrame: Day 30
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC
state: California
Study officials:
References: