Management of Drug Hypersensitivity in Children

Drug Hypersensitivity Clinical Trial

— DHC  

Official title:

Improved Management Based on Pathophysiology of Drug Hypersensitivity in Childhood

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02031120
• Other study ID #: UGeneva 13-006
• Status: Recruiting
• Phase: N/A
• First received: January 5, 2014
• Last updated: January 8, 2014
• Start date: January 2014
• Est. completion date: January 2019

Study information

• Verified date: January 2014
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: January 2019
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 16 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Drug Hypersensitivity
• Hypersensitivity

Locations

Country	Name	City	State
Switzerland	Geneva University Hospitals	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of suspected drug allergies in a pediatric hospital and the proportion in which these reactions are confirmed to be allergic		3 years	No
Secondary	Evaluation of the diagnostic values of the different allergy tests available	Sensitivity, specificity, negative and positive predictive value	3 years	No
Secondary	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	No