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Protocol of Reintroduction of Beta-lactams in Children at Low Risk of Anaphylaxis. (TRO-b-lact)

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03553251
Recruitment Status : Unknown
Verified June 2018 by Nantes University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : June 12, 2018
Last Update Posted : June 12, 2018
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Study Description
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Brief Summary:
The purpose of this study is to establish the rationale for the practice of performing an oral reintroduction test without previous skin tests in children at low risk of IgE-mediated reaction or drug-induced toxidermia, and to confirm the criteria for a drug reintroduction test could be performed without previous skin tests, without subsequent risk of reaction for the child. The primary endpoint will be the risk of a severe IgE-mediated or delayed hypersensitivity reaction in children who received beta-lactam drug reintroduction protocol prior to skin testing.

Condition or disease
Hypersensitivity Beta Lactam Adverse Reaction

Study Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Oral Beta-lactam Drug Reintroduction Protocol, Without Previous Skin Tests, in Children Under 16 Years of Age With a Clinical History That is Not Suggestive of Immunoglobulin E (IgE)-Mediated Anaphylaxis or Toxidermia to Beta-lactams.
Estimated Study Start Date : July 30, 2018
Estimated Primary Completion Date : July 30, 2019
Estimated Study Completion Date : July 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Anaphylaxis

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. low risk of 2% IgE-mediated or severe delayed hypersensitivity reactions following an oral beta-lactam drug reintroduction [ Time Frame: At the end of the study, after 2 years. ]
    Demonstrate a low risk of 2% IgE-mediated or severe delayed hypersensitivity reactions following an oral beta-lactam drug reintroduction, without previous skin tests, in children selected by a questionnaire as being at low risk of IgE-mediated or delayed


Secondary Outcome Measures :
  1. Risk evaluation [ Time Frame: At the end of the study, after 2 years. ]
    Evaluate a risk of IgE-mediated or delayed non-severe hypersensitivity reactions.

  2. explain the occurrence of a reaction of IgE-mediated or delayed hypersensitivity [ Time Frame: At the end of the study, after 2 years. ]
    If an IgE-mediated or delayed hypersensitivity reaction (s), severe or not, occurs during the oral beta-lactam drug reintroductions, analyze all the information collected in the inclusion questionnaire (s) of the patient (s) concerned, in order to find the element (s) most likely to explain the occurrence of a reaction of IgE-mediated or delayed hypersensitivity despite initial selection of patients at low risk of reaction.


Eligibility Criteria
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Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
children under 16 years of age with a clinical history that is not suggestive of IgE-mediated anaphylaxis or toxiderma to beta-lactams.
Criteria

Inclusion Criteria:

  • Children under 16 years of age coming for a consultation for a beta-lactam oral reintroduction test.

Exclusion Criteria:

  • Refusal of the legal representatives of the subject for their child to participate in the study,
  • If his age permits, refusal of the subject to participate in the study,
  • Subject aged over 16,
  • Pregnancy,
  • Absence of affiliation of the subject to a social security scheme,
  • Skin tests with incriminated beta-lactam already made before the consultation,
  • Existence of contraindications to the realization of oral reintroduction drug test with the suspected antibiotic,
  • Existence of criteria in the initial reaction suggestive of a non-low risk of IgE-mediated or delayed hypersensitivity to the incriminated beta-lactam, Taking antihistamine, corticosteroids or beta-blockers within 5 days prior to the oral reintroduction drug test,
  • Travel abroad of the child scheduled within 7 days of the oral reintroduction drug test.
Contacts and Locations
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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): NCT03553251


Contacts
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Contact: LUC COLAS, MD 02 53 48 21 80 ext +33 luc.colas@chu-nantes.fr

Sponsors and Collaborators
Nantes University Hospital
More Information
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT03553251    
Other Study ID Numbers: RC18_0193
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: June 12, 2018
Last Verified: June 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nantes University Hospital:
Hypersensitivity
Beta Lactam Adverse Reaction
Additional relevant MeSH terms:
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Hypersensitivity
Anaphylaxis
Immune System Diseases
Hypersensitivity, Immediate