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TerminatedNCT02031120DHCUpdated Mar 19, 2025

Management of Drug Hypersensitivity in Children

An observational study in Drug Hypersensitivity, sponsored by University Hospital, Geneva. Terminated at 1 site in Switzerland. Open to participants aged Up to 16 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-19.

Sponsored by University Hospital, Geneva · Observational

Why this study was terminated
Difficulty recruiting participants.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
207
Ages
Up to 16 Years
Sex
All
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Study 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.

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Conditions studied

  • Drug Hypersensitivity
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In context

Hypersensitivity

1,916 studies on the registry are indexed under Hypersensitivity; 265 are open to participants now.

This study's enrollment of 207 is above the median of 115 across 479 observational studies indexed under Hypersensitivity.

Browse Hypersensitivity studies →

Lead sponsor

University Hospital, Geneva is the lead sponsor of 372 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 16 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

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

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

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).
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
207 participants (actual)
Target follow-up
2 Years
Patient registry
Yes
Biospecimen retention
Samples with dna
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What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. Evaluation of the diagnostic values of the different allergy tests available

    Sensitivity, specificity, negative and positive predictive value

    Time frame: 3 years

  2. 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

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Study locations

1 site
  • Geneva University Hospitals
    Geneva, 1211, Switzerland
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02031120
Lead sponsor
University Hospital, Geneva
Responsible party
Jean-Christoph Caubet (Chef de clinique, University Hospital, Geneva) — Principal investigator
First posted
Jan 9, 2014
Start date
May 21, 2014
Primary completion
Feb 28, 2019
Completion
Feb 28, 2019
Last update
Mar 19, 2025

Study contacts

Jean-Christoph Caubet, MD
principal investigator · University Hospital, Geneva

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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