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Trial record 10 of 64 for:    Recruiting, Not yet recruiting, Available Studies | Drug allergy

Effect of Providing Stratification of Low Risk Penicillin Allergies on Penicillin Allergy Label Removal in ICU Setting

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ClinicalTrials.gov Identifier: NCT03702283
Recruitment Status : Recruiting
First Posted : October 11, 2018
Last Update Posted : August 21, 2019
Sponsor:
Collaborator:
Vanderbilt Institute for Clinical and Translational Research (Learning Healthcare System)
Information provided by (Responsible Party):
Elizabeth J Phillips, Vanderbilt University Medical Center

Brief Summary:
Currently it is estimated that at least 25 million people in the United States are labeled as penicillin allergic although less than 1.5 million of these are truly allergic. Although combined skin testing and oral challenge is an evidence-based de-labeling strategy the high burden of penicillin allergy labels means these services are available only through specialty allergy practices. There is therefore a need to provide evidence for alternative penicillin de-labeling strategies such as direct oral challenge. Previous studies have utilized quasi-experimental designs. Test dose challenges are currently recommended as a strategy for removal of low risk drug allergies, but the current experience is limited to single arm observational studies and evidence-based strategies for identifying low risk patients are lacking. The investigators objective is to demonstrate the benefit of providing risk stratification in removing penicillin allergy labels for low risk penicillin allergy patients in a randomized controlled trial.

Condition or disease Intervention/treatment Phase
Penicillin Allergy Other: Penicillin Allergic Risk Stratification Best Practice Alert Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Providing Stratification of Low Risk Penicillin Allergies on Penicillin Allergy Label Removal in ICU Setting
Actual Study Start Date : March 26, 2019
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
Drug Information available for: Penicillins

Arm Intervention/treatment
Experimental: Penicillin Allergic ICU Patients
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.
Other: Penicillin Allergic Risk Stratification Best Practice Alert
Providing best practice information on a patient's penicillin allergy risk and how to manage different levels of risk.




Primary Outcome Measures :
  1. Penicillin allergy label removal [ Time Frame: Hospital discharge at approximately 7 days after ICU transfer ]
    The proportion of patients with low risk penicillin allergy whose labels are removed from the medical chart's allergy section.

  2. Patients with low risk penicillin allergy label who underwent amoxicillin challenge [ Time Frame: Hospital discharge at approximately 7 days after ICU transfer ]
    The proportion of patients with low risk penicillin allergy who underwent amoxicillin challenge


Secondary Outcome Measures :
  1. Adverse events (in particular, reported allergic events) [ Time Frame: Hospital discharge at approximately 7 days after ICU transfer ]
    The proportion of penicillin allergic patients challenged with amoxicillin who reported adverse events

  2. Communication about penicillin allergy in discharge summary [ Time Frame: Hospital discharge at approximately 7 days after ICU transfer ]
    The proportion of penicillin allergic patients whose discharge summary contains information about penicillin allergy at discharge.

  3. Antibiotic utilization by patients [ Time Frame: Hospital discharge at approximately 7 days after ICU transfer ]
    The number of changes or new starts of penicillin treatments as a result of penicillin allergy label removal and the proportion of patients experiencing this event



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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • VUMC patients age 18 or older with a penicillin allergy reported in their chart and are medically stable, currently admitted to ICU.

Exclusion Criteria:

  • Patients with a penicillin allergy reported in their chart under ICU care, but who are currently medically unstable.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03702283


Contacts
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Contact: Cosby A Stone, MD, MPH 615-322-3412 cosby.a.stone@vumc.org

Locations
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United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Cosby A Stone, MD, MPH         
Sponsors and Collaborators
Vanderbilt University Medical Center
Vanderbilt Institute for Clinical and Translational Research (Learning Healthcare System)
Investigators
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Principal Investigator: Elizabeth J Phillips, MD Vanderbilt University Medical Center
Study Chair: Chris Lindsell, PhD Vanderbilt University Medical Center

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Responsible Party: Elizabeth J Phillips, Professor, Vanderbilt University Medical Center
ClinicalTrials.gov Identifier: NCT03702283     History of Changes
Other Study ID Numbers: 181734 -Pilot
First Posted: October 11, 2018    Key Record Dates
Last Update Posted: August 21, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypersensitivity
Drug Hypersensitivity
Immune System Diseases
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Penicillins
Anti-Bacterial Agents
Anti-Infective Agents