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NCT05464615 · ClinicalTrials.gov registry record · Early Phase 1
Geisinger Antibiotic Allergy Pilot Program: Assess and Address
A Early Phase 1 study of Penicillin Allergy, sponsored by Geisinger Clinic.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 100
- Enrollment target
- 3
- Study locations
NCT05464615 is a Early Phase 1 study of Penicillin Allergy that is actively recruiting participants, run by Geisinger Clinic. The registered enrollment target is 100 participants, below the 189-participant average among 3 other Penicillin Allergy trials with a reported enrollment target (47% lower). The trial reports 3 study locations across 1 state.
The verdict
NCT05464615, a Early Phase 1 study of Penicillin Allergy, is actively recruiting participants, sponsored by Geisinger Clinic.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 100 participants
- Enrollment target
- 3
- Study locations
Study Summary
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.
Conditions Studied
Interventions
- DRUG Amoxicillin
Study Locations (3)
Pennsylvania
- Geisinger Medical Center - Danville
- Geisinger Community Medical Center - Scranton
- Geisinger Wyoming Valley - Wilkes-Barre
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2024-03-04 |
| Est. Completion | 2025-12-31 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05464615
The ClinicalTrials.gov registry entry for NCT05464615 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 189-participant average among 3 other Penicillin Allergy trials with a reported enrollment target (47% lower). The listed sponsor is Geisinger Clinic, which has 107 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Penicillin Allergy appearing as the primary indexed condition, and to 1 intervention - of which Amoxicillin is the first listed.
NCT05464615 reports 3 study locations spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT05464615 about?
NCT05464615 is a clinical study titled "Geisinger Antibiotic Allergy Pilot Program: Assess and Address". 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 patien...
What is the current status of trial NCT05464615?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 100 participants. The study started on 2024-03-04. Estimated completion is 2025-12-31.
What conditions does trial NCT05464615 study?
This clinical trial studies the following conditions: Penicillin Allergy.
What interventions are being tested in trial NCT05464615?
The interventions under investigation include: Amoxicillin (DRUG).
Who is sponsoring clinical trial NCT05464615?
This trial is sponsored by Geisinger Clinic, which has 107 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05464615 being conducted?
This trial has 3 study locations across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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