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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000026980
Enrollment
40
Registered
2017-04-13
Start date
2017-04-15
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

In this study, we investigate drug hypersensitivity using a definitive diagnosis algorithm (modified Mirakian R. Clin Exp Allergy. 2009 Jan

Interventions

Blood test, skin prick test and provocation test.

Sponsors

Department of Pediatrics, Ehime University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Individuals with diagnosed and suspected drug hypersensitivity in Ehime University Hospital.

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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.

Countries

Japan

Contacts

Public ContactMiwa Shinohara

Ehime University Hospital Department of Pediatrics

shinohara.miwa.vv@ehime-u.ac.jp089-960-5320

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026