Allergy Delabeling in Antibiotic Stewardship - Intervention

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Ebbing Lautenbach
Study ID
NCT07133074
Status
Recruiting
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Conditions

  • Beta Lactam Allergy
  • Hematologic Malignancy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • RENEW-IN Algorithm for assessment of a beta-lactam intervention — DIAGNOSTIC_TEST
    The RENEW-IN intervention includes a detailed assessment of the participant's beta-lactam allergy history and determination of a risk-level for allergy-delabeling.
  • EMR Review — OTHER
    Electronic medical record review for comparative analysis

Study Details

The overall goal of the RENEW-IN intervention is to assess the impact of a BL allergy delabeling intervention on antibiotic use and clinical outcomes in patients with a hematologic malignancy.

Key Dates

Start date
Apr 20, 2026
Status verified
Apr 2026
Primary completion
Nov 30, 2028
Completion
Nov 30, 2029

Study Design

Enrollment
3,800 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Other: Patients who enroll in the RENEW intervention
    Patients who agree to actively participate in the RENEW intervention designed to identify opportunities to have the beta lactam allergy label removed from their electronic medical record.
  • Other: Patients hospitalized with a hematologic malignancy in the time period prior to the intervention
    Patients who are hospitalized with a hematologic malignancy who would meet the inclusion criteria for the intervention but who were not approached since they were hospitalized in the time period prior to introduction of the intervention. These patients will be used as a control group. Charts for these patients will be retrospectively reviewed and data will be extracted for analysis of the primary and secondary outcomes.

Primary Outcome Measure

Antibiotic Days of therapy [ Time Frame: From baseline enrollment to end of index hospitalization or death, up to 36 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Hospital of the University of PennsylvaniaPhiladelphiaPennsylvania19104
Ebbing Lautenbach, MD, MPH, MSCE

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By research site
Hospital of the University of Pennsylvania· Philadelphia, PA

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