PROlonged versus Single dose in PEnicillin oral Challenge Testing double-blind parallel randomized placebo cOntrolled tRial – PROSPECTOR-2 Study

Condition studied

Penicillin allergy

Investigational medicinal product(s)

Eligibility

Primary endpoint

Positive oral challenge (i.e. immune mediated reaction up to and including day 7 following the first test dose, number and percentage of participants), as adjudged by independent blinded panel

Endpoint detail

Positive oral challenge (i.e. immune mediated reaction up to and including day 14 following the first test dose, number and percentage of participants), as adjudged by independent blinded panel, Non-inferiority of single dose challenge to prolonged challenge (risk difference with two-sided 95% confidence interval using 10% as clinically relevant non-inferiority margin), Time to positive oral challenge, Quality of life (measured by Drug Hypersensitivity Quality of Life Questionnaire (DrHy-Q) at day 0 and 90