Analysis of differential gene and protein expression for the in vitro detection of drug allergy

• Conditions: Drug allergy; Z88; Personal history of allergy to drugs, medicaments and biological substances

• Registration Number: DRKS00026656
• Lead Sponsor: Bundesinstitut für Arzneimittel und MedizinprodukteAbteilung Forschung

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-08
• Study Completion: 2023-08-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

For patients: 1) Clinically documented association and confirmed diagnosis (medical history, skin tests, in vitro diagnostics if applicable) of drug allergy (for development and validation of the in vitro test system) or suspected drug allergy (patients with
suspected but not yet conclusively confirmed drug allergy) 2) Written and verbal consent to participate.

Exclusion Criteria

1) Lack of capacity to give consent to participate in the examination 2) Lack of temporal connection and evidence 3) Pregnancy

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Differential gene and protein expression of peripheral mononuclear cells of drug-allergic patients after in vitro stimulation with the drug blamed for allergy

Secondary Outcome Measures

Name	Time	Method
a) Establishment of a protocol that defines the methodology and the materials used as a basis for further development for a broader application in future <br>b) Determination of the drug-specific secretion<br>of selected cytokines (e.g. IFN-y, IL-5 and IL-13 e.g.<br>by ELISA)