Drug hypersensitivity study using a diagnosis algorithm to examinations of a suspected adverse drug reactio

Not Applicable

• Conditions: In this study, we investigate drug hypersensitivity using a definitive diagnosis algorithm (modified Mirakian R. Clin Exp Allergy. 2009 Jan; 39:43-61.) to examinations of a suspected adverse drug reaction.

• Registration Number: JPRN-UMIN000026980
• Lead Sponsor: Department of Pediatrics, Ehime University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-04-13
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Not provided

Exclusion Criteria

* Objectives without written informed concern. * Objectives judged as ineligible by the chief of the study. * Objectives with and suspected fetal and severe systemic drug reactions. * Objectives without healthy skin region to be performed skin tests. * Objectives without the skin region untreated by steroid ointments to be performed skin tests. * Objectives with intravenous steroid within 1 month. * Objectives with intravenous immunosuppressive agent within 1 month. * Objectives with oral antiallergic drug within 1 week. * Objectives with oral antihistamine within 1 week.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Our definitive diagnosis algorithm has 4 steps. Primary endpoints are 1) skin prick test is positive in Step 2, 2) provocation test is positive in Step 3, and 3) significant associations between HLA types and kind of drug that has positive reaction by provocation test in Step 2.