Clinical Trial: Management of Drug Hypersensitivity in Children

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]

Official Title: Improved Management Based on Pathophysiology of Drug Hypersensitivity in Childhood

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 Summary:
Sponsor: University Hospital, Geneva

Current Primary Outcome: 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 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Evaluation of the diagnostic values of the different allergy tests available [ Time Frame: 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 [ Time Frame: 3 years ]

Original Secondary Outcome: Same as current

Information By: University Hospital, Geneva

Dates:
Date Received: January 5, 2014
Date Started: January 2014
Date Completion: January 2019
Last Updated: January 8, 2014
Last Verified: January 2014