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

Hypersensitivity Clinical Trial

— TRO-b-lact  

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 Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03553251
• Other study ID #: RC18_0193
• Status: Not yet recruiting
• Start date: July 30, 2018
• Est. completion date: July 30, 2019

Study information

• Verified date: June 2018
• Source: Nantes University Hospital
• Contact: LUC COLAS, MD
• Phone: 02 53 48 21 80
• Email: luc.colas[@]chu-nantes.fr
• Is FDA regulated: No
• Study type: Observational

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: July 30, 2019
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anaphylaxis
• Beta Lactam Adverse Reaction
• Hypersensitivity

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Risk evaluation	Evaluate a risk of IgE-mediated or delayed non-severe hypersensitivity reactions.	At the end of the study, after 2 years.
Secondary	explain the occurrence of a reaction of IgE-mediated or delayed hypersensitivity	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.	At the end of the study, after 2 years.