A Study to Evaluate Quality of Life, Psychological Impact, and End Organ Damage in Survivors of Severe Drug Eruptions
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 19-012420
Sponsor Protocol Number: 09-012420
About this study
The purpose of this study is to determine the extent to which patients who survive severe drug eruptions suffer long-term end organ damage and experience decreased quality of life and psychological distress
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criterial:
- Patients must be able to speak and understand English.
- Participants must provide verbal informed consent.
- Participants must be age 18 or older.
- Both male and female patients will be included.
- Patients must have received a diagnosis of “severe drug eruption,” either SJS/TEN or DRESS syndrome to be included.
Exclusion Criteria:
- Children less than 18 years of age are excluded; there is reason to believe severe drug eruptions in this population have relatively better outcomes and potentially different psychological and quality of life effects than in an adult population.
- Patients unable or unwilling to provide informed consent
- Vulnerable populations will be excluded (children, fetuses, neonates, or prisoners).
- Women will not be asked information about pregnancy and therefore, pregnant women are neither targeted for participation but also not excluded because the information will not be known.
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
More information
Publications
Publications are currently not available