Management of Drug Hypersensitivity in Children

NCT02031120 | Terminated DMC

• 1 other identifier: UGeneva 13-006
• Study Type: observational
• Target: 207
• Locations: 1 country
• Sites: 1

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.

Conditions

Drug Hypersensitivity

Outcome Measures

Primary Outcomes (1)

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

  3 years

Secondary Outcomes (2)

• Evaluation of the diagnostic values of the different allergy tests available

  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

  3 years

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children with suspected drug allergies in a pediatric hospital (including ambulatory departments)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

Geneva University Hospitals

Geneva, 1211, Switzerland

Location

Biospecimen

Retention: SAMPLES WITH DNA

whole blood, serum, white cells

MeSH Terms

Conditions

Drug Hypersensitivity

Condition Hierarchy (Ancestors)

Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders

Study Officials

• Jean-Christoph Caubet, MD

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chef de clinique

Study Record Dates

• First Submitted: January 5, 2014
• First Posted: January 9, 2014
• Study Start: May 21, 2014
• Primary Completion: February 28, 2019
• Study Completion: February 28, 2019
• Last Updated: March 19, 2025

Record last verified: 2025-03

Locations

CH (1)