NCT05464615 Geisinger Antibiotic Allergy Pilot Program: Assess and Address
| NCT ID | NCT05464615 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Geisinger Clinic |
| Condition | Penicillin Allergy |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-03-04 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 100 participants in total. It began in 2024-03-04 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Hospitalized male or female patients with a history of Penicillin (PCN) allergy or PCN-derivative allergy as reported by patient or documented in Epic * ≥18 years of age * Patients with a medical need for treatment with a PCN or PCN-derivative or other beta-lactam antibiotics as determined by an inpatient provider * Able and willing to provide consent in English. Exclusion Criteria: * History of documented immediate-onset severe allergic reaction or delayed onset hypersensitivity reaction to a PCN or PCN-derivative * Patients who are hemodynamically unstable (e.g., pulse oximetry O2 saturation \<90 %, respiratory rate \>=21 per minute, severe hypoxia requiring non-invasive ventilation, high-flow nasal canula, or mechanical ventilation, refractory hypotension requiring vasopressor support, heart rate \>100 beats per minute, etc.) * Patients with uncontrolled pulmonary diseases (like exacerbation of asthma, Chronic Obstructive Pulmonary Disease (COPD), and/or other forms of chronic lung diseases)
Contact & Investigator
Taesung Kwon, MD
PRINCIPAL INVESTIGATOR
Geisinger Clinic
Frequently Asked Questions
Who can join the NCT05464615 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Penicillin Allergy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05464615 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05464615 currently recruiting?
Yes, NCT05464615 is actively recruiting participants. Contact the research team at kfrank6@geisinger.edu for enrollment information.
Where is the NCT05464615 trial being conducted?
This trial is being conducted at Danville, United States, Scranton, United States, Wilkes-Barre, United States.
Who is sponsoring the NCT05464615 clinical trial?
NCT05464615 is sponsored by Geisinger Clinic. The principal investigator is Taesung Kwon, MD at Geisinger Clinic. The trial plans to enroll 100 participants.