Drug Hypersensitivity | Management of Drug Hypersensitivity in Children
Drug Hypersensitivity research study
What is the primary objective of this study?
The aim of this study is (1) to assess the incidence of suspected drug allergies in a pediatric hospital and the proportion in which these reactions are confirmed to be allergic; (2) to evaluate the diagnostic values of the different allergy tests available; (3) to investigate the pathophysiology of drug allergies, particularly by investigating the role of viruses, and by performing HLA typing and a gene expression profile both in the acute phase of the reaction and 2 months later.
Who is eligible to participate?
Inclusion Criteria: - Participation will be proposed to any children (0 to 16 years) receiving one or several drug(s) and developing one of the following clinical manifestations: urticaria, maculopapular rash, bullous eruption, flush, anaphylaxis, serum sickness-like disease, SJS, TEN, DRESS or fever linked to drug intake. Exclusion Criteria: - Patients will be excluded if the symptoms occur more than 72 hours after any treatment was stopped or if the symptoms are clearly linked to another cause (measles, rubeola, roseola, varicella, fifth disease, Gianotti-Crosti syndrome, scarlet fever, Gibert's pityriasis or food allergy).
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Start Date: January 2014
Completed Date: January 2019
Type: Observational [Patient Registry]
Primary Outcome: Incidence of suspected drug allergies in a pediatric hospital and the proportion in which these reactions are confirmed to be allergic
Secondary Outcome: Evaluation of the diagnostic values of the different allergy tests available
Study sponsors, principal investigator, and references
Principal Investigator: Jean-Christoph Caubet, MD
Lead Sponsor: University Hospital, Geneva