Cyclosporine Vs Steroids in DRESS
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Cyclosporine, Methylprednisolone and Prednisone.
- Кому может быть актуально
- Состояния в реестре: DRESS Syndrome, Drug-Induced Hypersensitivity Syndrome. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
A Randomized Controlled Pilot Trial of Cyclosporine Vs Steroids in DRESS
Обзор
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).
Подробное описание
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.
Вмешательства
- Препарат Cyclosporine
Patients randomized to cyclosporine will be treated as mentioned under "Arm/Group Description" - Препарат Methylprednisolone and Prednisone
All patients randomized to steroids will initially be treated with IV methylprednisolone and eventually started on an oral prednisone taper.
Первичные конечные точки
- Percentage of patients with complete or near complete resolution of organ involvement at day 30, on steroid therapy and cyclosporine therapy [Срок оценки: Day 7]
- Percentage of patients with complete or near complete resolution of organ involvement at day 30, on steroid therapy and cyclosporine therapy [Срок оценки: Day 30]
- Percentage of patients with complete or near complete resolution of erythema at day 7, on steroid therapy and cyclosporine therapy [Срок оценки: Day 7]
- Percentage of patients with complete or near complete resolution of erythema at day 30, on steroid therapy and cyclosporine therapy [Срок оценки: Day 30]
Вторичные конечные точки (12)
- Percentage of patients with resolution of fever [Срок оценки: Day 7]
- Percentage of patients with resolution of fever [Срок оценки: Day 30]
- Percentage of patients with resolution of facial edema [Срок оценки: Day 7]
- Percentage of patients with resolution of facial edema [Срок оценки: Day 30]
- Percentage of patients with resolution of pruritus [Срок оценки: Day 7]
- Percentage of patients with resolution of pruritus [Срок оценки: Day 30]
- Percentage of patients with resolution of lymphadenopathy [Срок оценки: Day 7]
- Percentage of patients with resolution of lymphadenopathy [Срок оценки: Day 30]
- Absolute eosinophil proportion compared to peak value [Срок оценки: Day 7]
- Absolute eosinophil proportion compared to peak value [Срок оценки: Day 30]
- Patients with autoimmune disease development [Срок оценки: Day 30]
- Patients with autoimmune disease development [Срок оценки: Day 90]
Критерии участия
Критерии включения
- Adults with a RegiSCAR score of greater than 4 (i.e a likely diagnosis of DRESS)
Критерии исключения
- 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)
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Параллельные группы
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
США · 1 центр
- USC — Los Angeles
Идентификаторы
NCT: NCT04988256 · HS-20-00118