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Management of Drug Hypersensitivity in Children

Improved Management Based on Pathophysiology of Drug Hypersensitivity in Childhood

Status
Terminated
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02031120
Acronym
DHC
Enrollment
207
Registered
2014-01-09
Start date
2014-05-21
Completion date
2019-02-28
Last updated
2025-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug Hypersensitivity

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.

Interventions

None listed

Sponsors

University Hospital, Geneva
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 16 Years
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frame
Incidence of suspected drug allergies in a pediatric hospital and the proportion in which these reactions are confirmed to be allergic3 years

Secondary

MeasureTime frameDescription
Evaluation of the diagnostic values of the different allergy tests available3 yearsSensitivity, 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 later3 years

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026