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Showing 1-6 of 6 trials
NCT06406114
Cephalosporin antibiotics are commonly used but can result in allergic reactions and anaphylaxis. There is no clear diagnostic approach for cephalosporin-allergic patients, and guidance for the use of other antibiotics in allergic patients is based on side chain chemical similarity and limited skin testing evidence. This project includes a clinical trial and mechanistic studies to optimize the approach to cephalosporin allergy and advance future diagnostics.
NCT07390370
Immediate drug hypersensitivity reactions are acute adverse reactions that occur within one hour of drug administration and can result in life-threatening symptoms such as urticaria, angioedema, and anaphylaxis. Current diagnostic methods have high false-negative and false-positive rates, and standardized testing for non-IgE-mediated reactions (e.g., MRGPRX2) is lacking. This creates significant gaps in patient safety and clinical decision-making. The study aims to establish a registry of patients with immediate drug hypersensitivity reactions to analyze clinical characteristics and investigate the underlying mechanisms of IgE-mediated and non-IgE-mediated reactions. Blood samples will be collected prospectively, using residual serum from routine clinical tests where available, to minimize additional blood draws. Mechanistic analyses will focus on IgE-mediated and non-IgE-mediated pathways, including MRGPRX2 expression in mast cells and basophils, and measurement of active β-tryptase as a biomarker for anaphylaxis. In addition, a retrospective review will be conducted of medical records from the last 10 years to identify causative drugs and classify the underlying mechanisms of hypersensitivity. Based on this, specific target drugs will be selected for further prospective analysis. Data and biospecimens from participants in an existing allergy registry, who consent to secondary use, will also be included in the study. Through the integration of clinical data and multi-layered biomarker analysis, the study aims to improve understanding of immediate drug hypersensitivity mechanisms and develop predictive models. Ultimately, this research will contribute to the establishment of personalized diagnosis, prevention, and treatment strategies for drug allergies.
NCT07069439
This study aims to evaluate the psychometric properties of the Turkish version of the Parent-reported Drug Hypersensitivity Quality of Life Questionnaire (P-DrHy-Q), a disease-specific instrument assessing the health-related quality of life (HRQoL) in caregivers of children with suspected or confirmed drug hypersensitivity reactions. The P-DrHy-Q is designed to capture the psychosocial burden experienced by caregivers and includes two main domains: Mental Health and Social Activity. This study involves a forward-backward translation process, cultural adaptation, internal consistency analysis, and test-retest reliability assessment in a Turkish caregiver population.
NCT06523192
We aim to validate the English (UK) translation of the DrHy-Q, and test its reliability in the UK population. This will facilitate for the subsequent economical evaluation of penicillin allergy delabelling. This research project is part of an MSc in Allergy undertaken by the principal applicant, Dr Patricia Romero, supervised through Imperial College London. Target population are patients with a drug allergy diagnosed by an Allergist prospectively at the Drug Allergy Clinic. Is the English version of the Drug Hypersensitivity Quality of Life Questionnaire suitable to be used in the UK population?
NCT05269082
The aim of this study is to find out whether TAK-880 creates hypersensitivity reactions compared to Gammagard S/D by testing blood taken from participants who have a higher risk of becoming hypersensitive to immunoglobulin products. This study is about collecting data available in the participant's medical record. No study medicines will be provided to participants in this study. Each participant will fill out a study questionnaire during a routine doctor visit. Blood will be taken from participants who have a higher risk of developing hypersensitivity reactions to immunoglobulin products.
NCT03158831
The investigators are conducting a prospective study to determine the safety and outcomes of placebo-controlled graded drug challenges without prior skin testing in patients with a low-risk history of antibiotic hypersensitivity reaction based on history alone. The investigators hypothesize that the rate of reaction to graded drug challenges without prior skin testing in patients with a low-risk history of drug hypersensitivity reaction based on history alone will not be meaningfully more than the rate of reaction to placebo. The investigators hypothesize that the rate of adverse reactions to drug challenges without prior skin testing will not be meaningfully more than the rate of adverse reactions with prior skin testing as was observed in the investigators' historical clinic cohort.