Penicillin allergy
Conditions
Brief summary
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
Detailed description
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
Interventions
DRUGCapsugel Belgium N.V Empty hard gelatin capsules size AA Elong
DRUGDB-caps Part number G7ECL000020 see IMPD
DRUGAmoxicillin
Sponsors
Gentofte Hospital, Austin Health
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Belgium, Denmark
Outcome results
None listed