Management of Drug Hypersensitivity in Children

Terminated

• Conditions: Drug Hypersensitivity

• Registration Number: NCT02031120
• Lead Sponsor: University Hospital, Geneva

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-05
• Study First Submitted QC: 2014-01-08
• Study First Posted: 2014-01-09
• Study Start: 2014-05-21
• Primary Completion: 2019-02-28
• Study Completion: 2019-02-28
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-16
• Last Update Posted: 2025-03-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 207

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of suspected drug allergies in a pediatric hospital and the proportion in which these reactions are confirmed to be allergic	3 years

Secondary Outcome Measures

Name	Time	Method
Evaluation of the diagnostic values of the different allergy tests available	3 years	Sensitivity, specificity, negative and positive predictive value
Determination of the role of viruses, HLA typing and gene expression profile both in the acute phase of the reaction and 2 months later	3 years

Trial Locations

Locations (1)

Geneva University Hospitals; 🇨🇭 Geneva, Switzerland