AI-based expression analysis of marker genes for the in vitro detection of a drug sensitization - KIAM

Bundesinstitut für Arzneimittel und Medizinprodukte0 个研究点目标入组 100 人开始时间: 2023年8月30日最近更新: 2024年8月19日

适应症

试验速览

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•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;
•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;
•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.

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