Z88
Conditions
Interventions
Group 1: Peripheral blood mononuclear cells from drug-allergic patients and control persons are stimulated with the allergy-inducing drug. Then, the gene expression of selected marker genes is determi
Sponsors
Bundesinstitut für Arzneimittel und Medizinprodukte
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: For patients: Clinically documented correlation and optimally verified diagnosis (anamnesis, skin tests, if necessary in-vitro diagnostics) of a drug allergy (if necessary, patients with a strongly suspected drug allergy can also be included); Type I (immediate-type) or Type IV (delayed-type) reactions; No acute allergic reaction at the time of blood sampling; optimal: 2 - 8 weeks after the reaction, but also possible many years after the reaction; For controls: No history of an allergy to the tested drug
Exclusion criteria
Exclusion criteria: For patients: Inability to consent the participation; Missing verification of a drug allergy; Pregnancy; In case of an immunosuppressive therapy, the decision should be made on an individual basis. The data in the literature are inconsistent here. In one publication, a limit of 0.2 mg/kg prednisolone equivalent was mentioned. For controls: Inability to consent the participation; Indication or verification of a drug allergy to the tested drug; Pregnancy; In case of an immunosuppressive therapy, the decision should be made on an individual basis. The data in the literature are inconsistent here. In one publication, a limit of 0.2 mg/kg prednisolone equivalent was mentioned.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Results from the transfer, validation and robustness study (at least 30 drug-allergic patients and 30 controls) | — |
Secondary
| Measure | Time frame |
|---|---|
| Creation of a website prototype: The results of the expression data for the marker genes can be entered in a user-friendly interface of a website. According to these data, the presence of a drug-specific sensitization ("allergy status") should be provided by the website. | — |
Countries
Germany
Contacts
Public ContactBernhardt Sachs
Bundesinstitut für Arzneimittel und Medizinprodukte
Outcome results
None listed