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

Hypersensitivity Clinical Trial

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.

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03553251
Study type Observational
Source Nantes University Hospital
Contact LUC COLAS, MD
Phone 02 53 48 21 80
Email luc.colas@chu-nantes.fr
Status Not yet recruiting
Phase
Start date July 30, 2018
Completion date July 30, 2019
View Details
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