AI-based expression analysis of marker genes for the in vitro detection of a drug sensitizatio
- Conditions
- Z88Personal history of allergy to drugs, medicaments and biological substances
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
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
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.
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Results from the transfer, validation and robustness study (at least 30 drug-allergic patients and 30 controls)
- Secondary Outcome Measures
Name Time Method 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.