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Completed

NCT Number: NCT03553251

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

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.

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Key information

Conditions

Hypersensitivity Beta Lactam Adverse Reaction Immune System Diseases

Age range

Up to 16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Nantes University Hospital

Nantes, Loire-Atlantique, 44093, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

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

    Time frame: At the end of the study, after 2 years.

    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

Secondary outcomes

  1. Risk evaluation

    Time frame: At the end of the study, after 2 years.

    Evaluate a risk of IgE-mediated or delayed non-severe hypersensitivity reactions.

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

    Time frame: At the end of the study, after 2 years.

    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.

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study 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.

Acronym: TRO-b-lact

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 12, 2018
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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