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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

Tracking Information
First Submitted Date  ICMJE October 8, 2018
First Posted Date  ICMJE October 11, 2018
Last Update Posted Date August 21, 2019
Actual Study Start Date  ICMJE March 26, 2019
Estimated Primary Completion Date January 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 10, 2018)
  • 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.
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03702283 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2018)
  • 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
  • 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.
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Providing Stratification of Low Risk Penicillin Allergies on Penicillin Allergy Label Removal in ICU Setting
Official Title  ICMJE Effect of Providing Stratification of Low Risk Penicillin Allergies on Penicillin Allergy Label Removal in ICU Setting
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Penicillin Allergy
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Other: Penicillin Allergic Risk Stratification Best Practice Alert
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 10, 2018)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 31, 2020
Estimated Primary Completion Date January 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Cosby A Stone, MD, MPH 615-322-3412 cosby.a.stone@vumc.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03702283
Other Study ID Numbers  ICMJE 181734 -Pilot
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Elizabeth J Phillips, Vanderbilt University Medical Center
Study Sponsor  ICMJE Vanderbilt University Medical Center
Collaborators  ICMJE Vanderbilt Institute for Clinical and Translational Research (Learning Healthcare System)
Investigators  ICMJE
Principal Investigator: Elizabeth J Phillips, MD Vanderbilt University Medical Center
Study Chair: Chris Lindsell, PhD Vanderbilt University Medical Center
PRS Account Vanderbilt University Medical Center
Verification Date August 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP