Drug allergy Z88
Conditions
Interventions
Group 1: Differential gene and protein expression analysis of PBMCs from blood samples of patients and control persons after co-incubation with the suspected drug
Sponsors
Bundesinstitut für Arzneimittel und MedizinprodukteAbteilung Forschung
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
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
Exclusion criteria: 1) Lack of capacity to give consent to participate in the examination 2) Lack of temporal connection and evidence 3) Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Differential gene and protein expression of peripheral mononuclear cells of drug-allergic patients after in vitro stimulation with the drug blamed for allergy | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 b) Determination of the drug-specific secretion of selected cytokines (e.g. IFN-y, IL-5 and IL-13 e.g. by ELISA) | — |
Countries
Germany
Contacts
Public ContactBernhardt Sachs
Bundesinstitut für Arzneimittel und MedizinprodukteAbteilung Forschung
Outcome results
None listed