Amoxicillin trihydrate for Penicillin allergy

Inclusion criteria

• {"criterion_text":"- Adult patients referred to the outpatient allergy clinic or inpatient allergy service (with a non-infective diagnosis) for a penicillin allergy history (i.e. amoxicillin or penicillin unspecified)"}
• {"criterion_text":"- Adult patients with an immune-mediated penicillin allergy history: 1. Delayed phenotype (> 6 hours post dose) 2. Or unknown timing"}
• {"criterion_text":"- Tolerated first dose of an oral amoxicillin challenge"}
• {"criterion_text":"- Willing and able to give consent"}
• {"criterion_text":"- Willing and able to undergo telehealth or in clinic review post challenge"}
• {"criterion_text":"- Outpatients who are not currently receiving, or are not likely to receive, beta-lactam antibiotic therapy during the 14-day study period."}

Exclusion criteria

• {"criterion_text":"- Patient age is < 18 years"}
• {"criterion_text":"- Any other illness that, in the investigator’s judgement, will substantially increase the risk associated with subject’s participation in this study"}
• {"criterion_text":"- Stevens-Johnson Syndrome, Drug Reaction with Eosinophilia and Systemic Symptoms or Acute Generalized Exanthematous Pustulosis or Toxic Epidermal Necrolysis to penicillin’s or aminocephalosporins"}
• {"criterion_text":"- Concurrent use of antihistamines or systemic steroid therapy (> 10 mg daily)"}

Primary endpoints

• {"endpoint_text":"- 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","definition_or_measurement_approach":"Adjudged by an independent blinded panel; immune-mediated reaction occurring up to and including day 7 following the first test dose; reported as number and percentage of participants."}

Secondary endpoints

• {"endpoint_text":"- 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","definition_or_measurement_approach":"Adjudged by an independent blinded panel; immune-mediated reaction occurring up to and including day 14 following the first test dose; reported as number and percentage of participants."}
• {"endpoint_text":"- 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)","definition_or_measurement_approach":"Statistical non-inferiority comparison using risk difference with two-sided 95% CI and 10% non-inferiority margin."}
• {"endpoint_text":"- Time to positive oral challenge","definition_or_measurement_approach":"Measured time from first test dose to occurrence of a positive oral challenge."}
• {"endpoint_text":"- Quality of life (measured by Drug Hypersensitivity Quality of Life Questionnaire (DrHy-Q) at day 0 and 90","definition_or_measurement_approach":"DrHy-Q administered at day 0 and day 90 to assess quality of life."}

Methods

• Recruitment of adult patients referred to the outpatient allergy clinic or inpatient allergy service (with a non-infective diagnosis) for a penicillin allergy history.
• Use of recruitment materials (e.g. waiting room recruitment poster) as indicated by a 'recruitment poster for waiting room' document.
• Provision of subject information and informed consent forms (documents available for participating sites).

Belgium

Earliest CTIS Part Ii Submission Date

29-09-2025

Latest Decision Or Authorization Date

28-10-2025

Processing Time Days

29

Number Of Sites

1

Number Of Participants

80

Denmark

Earliest CTIS Part Ii Submission Date

13-10-2025

Latest Decision Or Authorization Date

28-10-2025

Processing Time Days

15

Number Of Sites

1

Number Of Participants

80

Primary sponsor

Full Name

Gentofte Hospital

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Denmark

Third parties

• {"country":"Belgium","full_name":"Universitair Ziekenhuis Antwerpen","duties_or_roles":"1","organisation_type":"Hospital/Clinic/Other health care facility"}
• {"country":"Denmark","full_name":"Region Hovedstaden","duties_or_roles":"1","organisation_type":"Hospital/Clinic/Other health care facility"}

Co-sponsors

• Austin Health