Management of Drug Hypersensitivity in Children (DHC)

Improved Management Based on Pathophysiology of Drug Hypersensitivity in Childhood

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 Overview

• Status: Unknown
• Conditions: Drug Hypersensitivity

• Study Type: Observational
• Enrollment (Anticipated): 250

Contacts and Locations

Study Locations

• Switzerland
  • Geneva, Switzerland, 1211
    • Recruiting
    • Geneva University Hospitals
    • Contact: Jean-Christoph Caubet, MD; Phone Number: +4179 5534085; Email: Jean-Christoph.Caubet@hcuge.ch
    • Contact: Philippe Eigenmann, MD; Phone Number: +4122 3824531; Email: Philippe.Eigenmann@hcuge.ch
    • Principal Investigator: Jean-Christoph Caubet, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
Evaluation of the diagnostic values of the different allergy tests available	Sensitivity, specificity, negative and positive predictive value	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

Collaborators and Investigators

• Sponsor: University Hospital, Geneva
• Investigators: Principal Investigator: Jean-Christoph Caubet, MD, University Hospital, Geneva

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Anticipated): January 1, 2017
• Study Completion (Anticipated): January 1, 2019

Study Registration Dates

• First Submitted: January 5, 2014
• First Submitted That Met QC Criteria: January 8, 2014
• First Posted (Estimate): January 9, 2014

Study Record Updates

• Last Update Posted (Estimate): January 9, 2014
• Last Update Submitted That Met QC Criteria: January 8, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Immune System Diseases; Drug-Related Side Effects and Adverse Reactions; Hypersensitivity; Drug Hypersensitivity
• Other Study ID Numbers: UGeneva 13-006