Protocol of Reintroduction of Beta-lactams in Children at Low Risk of Anaphylaxis.

NCT03553251 | Unknown

• 1 other identifier: RC18_0193
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hypersensitivity; Beta Lactam Adverse Reaction

Keywords

Hypersensitivity; Beta Lactam Adverse Reaction

Outcome Measures

Primary Outcomes (1)

• low risk of 2% IgE-mediated or severe delayed hypersensitivity reactions following an oral beta-lactam drug reintroduction

  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

  At the end of the study, after 2 years.

Secondary Outcomes (2)

• Risk evaluation

  At the end of the study, after 2 years.

• explain the occurrence of a reaction of IgE-mediated or delayed hypersensitivity

  At the end of the study, after 2 years.

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nantes University Hospital: lead

MeSH Terms

Conditions

Hypersensitivity

Condition Hierarchy (Ancestors)

Immune System Diseases

Central Study Contacts

LUC COLAS, MD

CONTACT

02 53 48 21 80; luc.colas@chu-nantes.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2018
• First Posted: June 12, 2018
• Study Start: July 30, 2018
• Primary Completion: July 30, 2019
• Study Completion: July 30, 2019
• Last Updated: June 12, 2018

Record last verified: 2018-06