Management of Drug Hypersensitivity in Children | NCT02031120

Studies
Management of Drug Hypersensitivity in Children

NCT02031120

Sponsor

University Hospital, Geneva

Status

Terminated

Last Update Posted

Mar 19, 2025Actual

Enrollment

207Actual

Phase

Not provided

Conditions

Drug Hypersensitivity

Interventions

Not provided

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2025

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Difficulty recruiting participants.

Expanded Access Info

Start Date

May 21, 2014Actual

Primary Completion Date

Feb 28, 2019Actual

Completion Date

Feb 28, 2019Actual

First Submitted Date

Jan 5, 2014

First Submission Date that Met QC Criteria

Jan 8, 2014

First Posted Date

Jan 9, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 16, 2025

Last Update Posted Date

Mar 19, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

207Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of suspected drug allergies in a pediatric hospital and the proportion in which these reactions are confirmed to be allergic		3 years

Secondary Outcomes

Measure	Description	Time Frame
Evaluation of the diagnostic values of the different allergy tests available	Sensitivity, specificity, negative and positive predictive value	3 years
Determination of the role of viruses, HLA typing and gene expression profile both in the acute phase of the reaction and 2 months later

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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).

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

16 Years

Standard Ages

Child

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jean-Christoph Caubet, MD	University Hospital, Geneva	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Geneva University Hospitals		Geneva		1211	Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D004342	Drug Hypersensitivity

Ancestor Terms

ID	Term
D064420	Drug-Related Side Effects and Adverse Reactions
D064419	Chemically-Induced Disorders

Browse Leaves

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Browse Branches

Not provided