Management of Drug Hypersensitivity in Children

NCT ID: NCT02031120

Last Updated: 2025-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

207 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-05-21

Study Completion Date

2019-02-28

Brief Summary

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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 Description

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Conditions

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Drug Hypersensitivity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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).
Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Geneva

OTHER

Sponsor Role lead

Responsible Party

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Jean-Christoph Caubet

Chef de clinique

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jean-Christoph Caubet, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Geneva

Locations

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Geneva University Hospitals

Geneva, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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UGeneva 13-006

Identifier Type: -

Identifier Source: org_study_id

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