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

Nantes University Hospital (NUH)

Status: Unknown

Conditions: Beta Lactam Adverse Reaction; Hypersensitivity

Study type: Observational

Funder types: Other

Identifiers

NCT03553251

RC18_0193

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: Under 16 years old

Volunteers: Accepts Healthy Volunteers

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.