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Drug Hypersensitivity | Management of Drug Hypersensitivity in Children

Drug Hypersensitivity research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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).

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Drug Hypersensitivity

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Study Status

Recruiting

Start Date: January 2014

Completed Date: January 2019

Phase:

Type: Observational [Patient Registry]

Design:

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

Secondary Outcome: Evaluation of the diagnostic values of the different allergy tests available

Study sponsors, principal investigator, and references

Principal Investigator: Jean-Christoph Caubet, MD

Lead Sponsor: University Hospital, Geneva

Collaborator:

More information:https://clinicaltrials.gov/show/NCT02031120

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