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Management of Drug Hypersensitivity in Children (DHC)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University Hospital, Geneva
Sponsor:
Information provided by (Responsible Party):
Jean-Christoph Caubet, University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT02031120
First received: January 5, 2014
Last updated: January 8, 2014
Last verified: January 2014
  Purpose

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.


Condition
Drug Hypersensitivity

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Improved Management Based on Pathophysiology of Drug Hypersensitivity in Childhood

Resource links provided by NLM:


Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluation of the diagnostic values of the different allergy tests available [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Sensitivity, 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 later [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

whole blood, serum, white cells


Estimated Enrollment: 250
Study Start Date: January 2014
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   up to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02031120

Locations
Switzerland
Geneva University Hospitals Recruiting
Geneva, Switzerland, 1211
Contact: Jean-Christoph Caubet, MD    5534085 ext +4179    Jean-Christoph.Caubet@hcuge.ch   
Contact: Philippe Eigenmann, MD    3824531 ext +4122    Philippe.Eigenmann@hcuge.ch   
Principal Investigator: Jean-Christoph Caubet, MD         
Sponsors and Collaborators
University Hospital, Geneva
Investigators
Principal Investigator: Jean-Christoph Caubet, MD University Hospital, Geneva
  More Information

No publications provided

Responsible Party: Jean-Christoph Caubet, Chef de clinique, University Hospital, Geneva
ClinicalTrials.gov Identifier: NCT02031120     History of Changes
Other Study ID Numbers: UGeneva 13-006
Study First Received: January 5, 2014
Last Updated: January 8, 2014
Health Authority: Switzerland: Ethikkommission

Additional relevant MeSH terms:
Hypersensitivity
Drug Hypersensitivity
Immune System Diseases
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders

ClinicalTrials.gov processed this record on September 18, 2014