Geisinger Antibiotic Allergy Pilot Program: Assess and Address
Public ClinicalTrials.gov record NCT05464615. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Geisinger Antibiotic Allergy Pilot Program: Assess and Address (GAAP) Penicillin Allergy De-labeling in Inpatient Setting by Performing Direct Oral Amoxicillin Challenge in Low-risk Patients
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a prospective non-inferiority study to evaluate penicillin allergy history in patients with reported penicillin allergy, who require penicillin or penicillin-derivative antibiotic during inpatient admission using a focused questionnaire. A simplified scoring system will be assigned to patient responses, and the total score will be utilized to identify low-risk patients that have a minimal risk of allergic reactions on exposure to penicillin or its derivative. Patients determined to have low risk based on this questionnaire will be offered a test dose (graded challenge) of amoxicillin in a supervised setting, and if they tolerate it, penicillin allergy label will be removed from patient's chart. We hypothesize that at least 95% of low-risk patients will successfully pass the graded amoxicillin challenge so the penicillin allergy label can be removed from their charts. A proportion as low as 0.85 would be a good clinical outcome and considered non-inferior to the expected proportion of 0.95.
Study identification
- NCT ID
- NCT05464615
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Early Phase 1
- Enrollment
- 20 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 3, 2024
- Primary completion
- Jan 19, 2026
- Completion
- Jan 19, 2026
- Last update posted
- Jul 19, 2026
2024 – 2026
United States locations
- U.S. sites
- 4
- U.S. states
- 1
- U.S. cities
- 4
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Geisinger Medical Center | Danville | Pennsylvania | 17822 | — |
| Geisinger Lewistown Hospital | Lewiston | Pennsylvania | 17044 | — |
| Geisinger Community Medical Center | Scranton | Pennsylvania | 18510 | — |
| Geisinger Wyoming Valley | Wilkes-Barre | Pennsylvania | 18711 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05464615, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jul 19, 2026 · Synced Sep 8, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05464615 live on ClinicalTrials.gov.