Management of Drug Hypersensitivity in Children

N/ATerminatedNCT02031120

University Hospital, Geneva207 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

207

Conditions

Drug Hypersensitivity

Eligibility

Sex: ALLMax age: 16 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Locations (1)

Geneva University Hospitals

Geneva, Switzerland

Outcomes

Primary Outcomes

Incidence of suspected drug allergies in a pediatric hospital and the proportion in which these reactions are confirmed to be allergic

Time frame: 3 years

Secondary Outcomes

Evaluation of the diagnostic values of the different allergy tests available

Sensitivity, specificity, negative and positive predictive value

Time frame: 3 years

Determination of the role of viruses, HLA typing and gene expression profile both in the acute phase of the reaction and 2 months later

Time frame: 3 years

Data from ClinicalTrials.gov

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