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Trial record 1 of 27 for:    Recruiting, Not yet recruiting, Available Studies | "Drug Hypersensitivity"
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Management of Drug Hypersensitivity in Children (DHC)

This study is currently recruiting participants.
Verified January 2014 by Jean-Christoph Caubet, University Hospital, Geneva
Sponsor:
ClinicalTrials.gov Identifier:
NCT02031120
First Posted: January 9, 2014
Last Update Posted: January 9, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Jean-Christoph Caubet, University Hospital, Geneva
  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 Jean-Christoph Caubet, 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 ]

Secondary Outcome Measures:
  • Evaluation of the diagnostic values of the different allergy tests available [ Time Frame: 3 years ]
    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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: January 5, 2014
First Posted: January 9, 2014
Last Update Posted: January 9, 2014
Last Verified: January 2014

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