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Penicillin Allergic Risk Stratification Best Practice Alert for Penicillin Allergy

N/A

Waitlist Available

Led By Cosby Stone, MD, MPH

Research Sponsored by Vanderbilt University Medical Center

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 from 3-18 months of follow up

Awards & highlights

Study Summary

This trial is testing whether direct oral challenge is a safe and effective way to remove penicillin allergy labels for low risk patients.

Eligible Conditions

Penicillin Allergy

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from 3-18 months of follow up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from 3-18 months of follow up

This trial's timeline: 3 weeks for screening, Varies for treatment, and from 3-18 months of follow up for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Patients with low risk penicillin allergy label who underwent amoxicillin challenge

Penicillins

Secondary outcome measures

Adverse events (in particular, reported allergic events)

Antibiotic utilization by patients

Communication about penicillin allergy in discharge summary

+4 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Penicillin Allergic Floor Patients- ExperimentalExperimental Treatment1 Intervention

The intervention will provide access to a best-practices alert containing a penicillin allergy risk stratification tool and recommendations on whether to use an oral amoxicillin test dose challenge order set for patients who stratify as low risk.

Group II: Penicillin Allergic Floor Patients- ControlActive Control1 Intervention

Patients will receive current standard of care for penicillin allergy, which typically involves physician judgement on challenges versus consultation of allergy service.

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Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor

856 Previous Clinical Trials

670,152 Total Patients Enrolled

2 Trials studying Penicillin Allergy

260 Patients Enrolled for Penicillin Allergy

Vanderbilt Institute for Clinical and Translational Research (Learning Healthcare System)UNKNOWN

1 Previous Clinical Trials

240 Total Patients Enrolled

1 Trials studying Penicillin Allergy

240 Patients Enrolled for Penicillin Allergy

Chris Lindsell, PhDStudy ChairVanderbilt University Medical Center

1 Previous Clinical Trials

240 Total Patients Enrolled

1 Trials studying Penicillin Allergy

240 Patients Enrolled for Penicillin Allergy

Frequently Asked Questions

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

Does this research protocol consider those above the age of twenty?

"People who meet the eligibility criteria for this experiment must be between 18 and 99 years of age. Separately, 82 individuals under 18 years old and 157 over 65 have undergone related studies."

Answered by AI

Who meets the criteria for inclusion in this research trial?

"This medical trial is enrolling 2040 individuals aged 18-99 who suffer from a penicillin allergy. To take part, these patients must be currently admitted to either the stepdown unit or regular floor bed at VUMC and deemed medically stable by their attending physician."

Answered by AI

What positive effects is this research project aiming to achieve?

"The primary goal of this trial, measured after a patient's hospital discharge at 4 days following admittance, is to observe the effects on individuals with low-risk penicillin allergies who have taken amoxicillin. Secondary objectives include tracking the time period between penicillin allergy label removal and return, assessing communication about such allergies in discharge summaries, and gauging antibiotic utilization by patients both during their stay and post-discharge."

Answered by AI

Are additional participants still being sought for this experiment?

"According to the clinicaltrials.gov website, this medical trial is not presently enrolling patients. Initially posted on November 11th 2020 and last updated April 5th 2022, there are currently 257 other trials that remain actively recruiting participants at the present time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Effect of Providing Stratification of Low Risk Penicillin Allergies on Penicillin Allergy Label Removal

Cosby Stone 2020. "The Effect of Providing Stratification of Low Risk Penicillin Allergies on Penicillin Allergy Label Removal". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03702270.