Safety and Efficacy of an Oral Penicillin Challenge in Low Risk Hospitalized Patients

April 12, 2023 updated by: Saskatchewan Health Authority - Regina Area

Penicillin allergy is the most common drug allergy reported by patients. Approximately 10% of the population and 20% of inpatients carry a label of penicillin allergy. However, less than 5%-10% of them have a confirmed allergy following comprehensive investigations. Reported penicillin allergy leads to higher medical costs and excess complications and presents a major challenge to antimicrobial stewardship.

There is a high demand for allergy services however penicillin allergy testing (including skin testing and oral drug challenge) is not routinely available for inpatients even in major centres. Direct oral amoxicillin challenges are safe and effective in delabeling low risk patients who report penicillin allergy in large paediatric and adult studies and does not necessitate specialist referral.

The study team seeks to determine the safety and efficacy of a single-dose oral penicillin challenge pilot program in adult in-patients with self-reported penicillin allergy admitted to hospital under the internal medicine Clinical Teaching Unit (CTU). The study investigators will determine the number of patients successfully delabelled of their "penicillin allergy" prior to discharge from hospital over a 12 month period. The study doctors will also assess the economic impact of the investigator's model and ease of implementation in the busy inpatient setting. In the future this model could be implemented generally as an inpatient or outpatient penicillin allergy program where low risk patients, who do not require referral to an allergist, are expeditiously delabelled.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Penicillin allergy is the most common drug allergy reported by patients. Approximately 10% of the population and 20% of inpatients carry a label of penicillin allergy. However, only <5%-10% of them have a confirmed allergy following comprehensive investigations. Reported penicillin allergy leads to higher medical costs and excess complications and presents a major challenge to antimicrobial stewardship. There is a high demand for allergy services however penicillin allergy testing (including skin testing and oral drug challenge) is not routinely available for inpatients even in major centres. Consequently, patients with a penicillin allergy label receive alternative antibiotics such as carbapenems, fluoroquinolones, and vancomycin for the treatment of common and serious infections and for pre-surgical prophylaxis. Patients with penicillin allergy label have longer hospital stays and higher rates of infections with Clostridioides (Clostridium) difficile, VRE and MRSA in comparison with patients without a documented allergy.

Direct oral amoxicillin challenges are safe and effective in delabeling patients stratified as low risk for penicillin allergy in large pediatric and adult studies. Low-risk penicillin allergy histories include patients who have had isolated nonallergic symptoms (eg, gastrointestinal symptoms) or patients solely with a family history of a penicillin allergy, pruritus without rash, or remote (>10 years) unknown reactions without features suggestive of an IgE-mediated reaction.

The study investigators seek to determine the safety and efficacy of a single-dose oral penicillin challenge pilot program in adult in-patients with self-reported penicillin allergy admitted to hospital under the internal medicine Clinical Teaching Unit (CTU). Identified patients that fulfill the exclusion and inclusion criteria will be reviewed at the time of discharge for suitability, as per the algorithm, modelled after a previous study of similar design. Based on patient's reported allergy, and upon obtaining informed consent, participants will receive a supervised challenge of amoxicillin 250 mg once orally and subsequently observed for 1 hour before discharge home. After antibiotic challenge, patient outcome will be defined as (1) tolerated oral challenge with no adverse drug reaction or (2) adverse drug reaction.

By challenging carefully selected low risk patient that are unlikely to be truly allergic while in hospital, the study doctors can delabel patients of their "penicillin allergy" and as a result cut health care expenditures and promote good antimicrobial stewardship. In the future this model could be implemented generally as an inpatient or outpatient penicillin allergy program where low risk patients, who do not require referral to an allergist, are expeditiously delabeled.

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Assessed to be low risk of having a penicillin allergy as per the risk stratification questionnaire
  2. One of the following: i) An unknown reaction >10 years before, ii) A type A adverse drug reaction (pharmacologically predictable drug side effect or intolerance), or iii) A history of a benign childhood rash, nonurticarial rash, or maculopapular exanthem more than 10 years ago
  3. Age 18 years or older
  4. Hemodynamically stable and suitable for discharge home

Exclusion Criteria:

  1. Declines participation in the study
  2. Cognitive impairment and where a collateral history could not be obtained
  3. History of anaphylaxis or angioedema attributed to a penicillin-based antibiotic
  4. History of severe cutaneous adverse reactions attributed to a penicillin-based antibiotic
  5. History of acute kidney injury or severe liver impairment attributed to a penicillin-based antibiotic
  6. Currently taking an angiotensin-converting enzyme inhibitor, angiotensin-receptor blocker or a beta blocker
  7. Hemodynamically unstable
  8. History of idiopathic urticaria or idiopathic anaphylaxis
  9. Currently taking an antibiotic(s) for treatment of an active infection

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Amoxicillin administration
Oral amoxicillin administered to study patients
Drug: Amoxicillin 250 MG
Low dose oral amoxicillin will be administered to patients enrolled in the study meeting the inclusion and exclusion criteria.
Other Names:
  • Amoxicillin 250 mg Capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients tolerating oral amoxicillin challenge
Time Frame: 12 months
The number of patients tolerating a single dose oral amoxicillin (250 mg) challenge without adverse reaction(s) up to one hour of administration
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients reporting a delayed reaction to amoxicillin
Time Frame: 12 months
Number of patients reporting a delayed reaction to amoxicillin (between 1 hour - 12 weeks) following observation and discharge from hospital
12 months
Average delay in discharge attributable to amoxicillin challenge
Time Frame: 12 months
Average delay in discharge (minutes) attributable to penicillin challenge, recorded by the resident or staff physician performing the questionnaire
12 months
The number of patients excluded from the study due to staff time constraints
Time Frame: 12 months
Number of patients excluded from the study due to resident/staff time constraints
12 months
Type of immediate reaction attributed to the oral amoxicillin: maculopapular rash, urticaria, angioedema, airway compromise, diarrhea, vomiting or other (including subjective symptoms)
Time Frame: 12 months
Nature of immediate adverse reaction if challenge unsuccessful
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saskatchewan Health Authority - Regina Area

Investigators

  • Principal Investigator: Andrea Fong, MD, FRCPC, Saskatchewan Health Authority - Regina Area

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2023

Primary Completion (Anticipated)

March 1, 2024

Study Completion (Anticipated)

June 1, 2024

Study Registration Dates

First Submitted

February 3, 2020

First Submitted That Met QC Criteria

May 28, 2020

First Posted (Actual)

May 29, 2020

Study Record Updates

Last Update Posted (Estimate)

April 13, 2023

Last Update Submitted That Met QC Criteria

April 12, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REB-19-97

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No only agregate data will be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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