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The Use of Penicillin Allergy Clinical Decision Rule to Enable Direct Oral Penicillin Challenge

NCT04454229 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 382

Last updated 2023-03-06

No results posted yet for this study

Summary

Whilst validated tools exist to enable inpatient penicillin assessment and de-labelling, limited evidence is available regarding the safety and efficacy in the outpatient clinic. The ability to deliver point-of-care penicillin allergy testing for a large cohort of patients, without skin testing, will improve patient access to testing and utilization of preferred penicillin antibiotics.

Conditions

  • Hypersensitivity, Immediate
  • Hypersensitivity, Delayed
  • Hypersensitivity Response

Interventions

OTHER

Direct oral penicillin challenge

The patient will receive a single dose of oral penicillin, following baseline vital signs.

OTHER

Standard of care

Routine management as per the treating clinicians that include skin prick and intradermal beta-lactam testing, followed by oral penicillin challenge in the setting of negative skin testing.

Sponsors & Collaborators

  • Austin Health

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2022-12-02
Completion
2022-12-02

Countries

  • United States
  • Australia
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04454229 on ClinicalTrials.gov