Trials / Unknown
UnknownNCT03553251
Protocol of Reintroduction of Beta-lactams in Children at Low Risk of Anaphylaxis.
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.
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 200 (estimated)
- Sponsor
- Nantes University Hospital · Academic / Other
- Sex
- All
- Age
- 16 Years
- Healthy volunteers
- Accepted
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.
Conditions
Timeline
- Start date
- 2018-07-30
- Primary completion
- 2019-07-30
- Completion
- 2019-07-30
- First posted
- 2018-06-12
- Last updated
- 2018-06-12
Source: ClinicalTrials.gov record NCT03553251. Inclusion in this directory is not an endorsement.