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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03553251
Other study ID # RC18_0193
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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.
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