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Direct oral penicillin challenge for Allergy (PALACE Trial)

N/A

Waitlist Available

Research Sponsored by Austin Health

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 48h after the drug challenge

Awards & highlights

PALACE Trial Summary

This trial is testing a new way to test for penicillin allergies that doesn't require skin testing. The hope is that this will improve access to preferred penicillin antibiotics for patients.

Eligible Conditions

Allergy
Delayed Hypersensitivity

PALACE Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ before randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~before randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and before randomization for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The difference in the proportion of positive oral challenges (i.e. immune-mediated reaction)

Secondary outcome measures

Assessment with the Pre-Questionnaire and the 6 months follow-up Questionnaire

Feasibility of intervention delivery defined as the proportion of patients randomized to the intervention arm who had the intervention delivered as per protocol. [Intervention to recruitment ratio]

Feasibility of recruitment defined as the proportion of patients consenting to participate in the study as per protocol from eligible patients. [Recruitment to eligibility ratio].

+9 more

PALACE Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Direct oral antibiotic challengeExperimental Treatment1 Intervention

Direct oral antibiotic (penicillin) challenge in patients with PEN-Fast less than 3.

Group II: Standard of careActive Control1 Intervention

Standard of care: skin testing and, if negative, oral challenge.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Austin HealthLead Sponsor

62 Previous Clinical Trials

30,607 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this investigation currently have room for participants?

"Affirmative. Details on clinicaltrials.gov denote that this investigation is currently recruiting participants, which was initially published on July 1st 2021 and most recently modified on November 25th 2022. A total of 380 patients are needed across 4 different research centres."

Answered by AI

How many individuals are participating in this clinical research?

"Affirmative, clinicaltrials.gov indicates that recruitment for this research project is still ongoing. The trial was first advertised on July 1st 2021 and most recently updated in November 25th 2022. This study requires 380 participants across 4 different medical centres."

Answered by AI

Recent research and studies

JAMA Internal MedicineJournal

Development and Validation of a Penicillin Allergy Clinical Decision Rule

Trubiano, Jason A., Sara Vogrin, Kyra Y. L. Chua, Jack Bourke, James Yun, Abby Douglas, Cosby A. Stone, et al.. 2020. “Development and Validation of a Penicillin Allergy Clinical Decision Rule”. JAMA Internal Medicine. American Medical Association (AMA). doi:10.1001/jamainternmed.2020.0403.

The Journal of Allergy and Clinical Immunology: In PracticeJournal

Pathways to Improved Antibiotic Allergy and Antimicrobial Stewardship Practice: The Validation of a Beta-lactam Antibiotic Allergy Assessment Tool

Devchand, Misha, Karen F. Urbancic, Sharmila Khumra, Abby P. Douglas, Olivia Smibert, Emma Cohen, Michael Sutherland, Elizabeth J. Phillips, and Jason A. Trubiano. 2019. “Pathways to Improved Antibiotic Allergy and Antimicrobial Stewardship Practice: The Validation of a Beta-lactam Antibiotic Allergy Assessment Tool”. The Journal of Allergy and Clinical Immunology: In Practice. Elsevier BV. doi:10.1016/j.jaip.2018.07.048.

Open Forum Infectious DiseasesJournal

The Safety and Efficacy of an Oral Penicillin Challenge Program in Cancer Patients: A Multicenter Pilot Study

Trubiano, Jason A, Olivia Smibert, Abby Douglas, Misha Devchand, Belinda Lambros, Natasha E Holmes, Kyra Y Chua, Elizabeth J Phillips, and Monica A Slavin. 2018. “The Safety and Efficacy of an Oral Penicillin Challenge Program in Cancer Patients: A Multicenter Pilot Study”. Open Forum Infectious Diseases. Oxford University Press (OUP). doi:10.1093/ofid/ofy306.

BMJ OpenJournal