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Beta-lactam Antibiotic

Amoxicillin for Penicillin Allergy (GAAP Trial)

Phase < 1

Recruiting

Led By Taesung Kwon, MD

Research Sponsored by Geisinger Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

≥18 years of age

Able and willing to provide consent in English.

Must not have

Patients with uncontrolled pulmonary diseases (like exacerbation of asthma, Chronic Obstructive Pulmonary Disease (COPD), and/or other forms of chronic lung diseases)

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.)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up surveys will be sent to participating providers 1-2 weeks post administration of the gaap questionnaire.this process will be completed within 1 year post implementation of the protocol.

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to determine if patients with a reported penicillin allergy can safely receive penicillin or its derivatives. Patients will be asked specific questions to determine their risk of an allergic reaction. Low

Who is the study for?

This trial is for hospitalized adults who have a history of penicillin allergy noted in their medical records or reported by themselves. They must need treatment with penicillin or similar antibiotics and be able to consent in English.

What is being tested?

The study tests if patients with low-risk scores from a questionnaire can safely take amoxicillin, a penicillin derivative. Those who pass the test dose without an allergic reaction may have their penicillin allergy label removed.

What are the potential side effects?

Possible side effects include allergic reactions ranging from mild skin rashes to severe reactions like difficulty breathing and swelling, which will be closely monitored during the supervised setting.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I can and agree to consent in English.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have uncontrolled lung problems like severe asthma or COPD.

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I am not experiencing severe breathing or heart issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ allergic reactions in low-risk patients investigators will review and analyze the number and types of post-challenge allergic reaction in low risk patients within 1 year post implementation of the protocol

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~allergic reactions in low-risk patients investigators will review and analyze the number and types of post-challenge allergic reaction in low risk patients within 1 year post implementation of the protocol

This trial's timeline: 3 weeks for screening, Varies for treatment, and allergic reactions in low-risk patients investigators will review and analyze the number and types of post-challenge allergic reaction in low risk patients within 1 year post implementation of the protocol for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Success Rate of the Graded Amoxicillin Challenge

Secondary study objectives

Allergic reactions in low-risk patients

Provider input on the GAAP Questionnaire to Identify Risk levels

Side effects data

From 2023 Phase 4 trial • 23 Patients • NCT05010304

Rash

100%

80%

60%

40%

20%

Study treatment Arm

Pediatric Patients With a History of Penicillin Allergy

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Amoxicillin Graded ChallengeExperimental Treatment1 Intervention

1. Obtain baseline vitals (heart rate, O2 saturation, blood pressure and respiratory rate). 2. Administer 0.7 ml (56 mg) of amoxicillin 400 mg/ 5ml orally followed by 30 minutes of observation for allergy symptoms and other adverse reactions (e.g., itching, hives, swelling, coughing, wheezing, throat tightness, difficulty breathing, abdominal pain, vomiting, lightheadedness, hypotension, low oxygen saturation, tachycardia) 3. If no allergy or adverse symptoms are noted, administer 2.5 ml (200 mg) of amoxicillin followed by 90 minutes of observation

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Amoxicillin

2017

Completed Phase 4

~7780

0 / 4Eligibility criteria met