Allergy Delabeling in Antibiotic Stewardship - Intervention

NCT ID: NCT07133074

Last Updated: 2026-01-20

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 3800 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-02-28
• Study Completion Date: 2029-11-30

Brief Summary

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.

Detailed Description

The RENEW clinical intervention is designed to evaluate the impact of a comprehensive beta lactam allergy delabeling intervention on clinical outcomes among patients hospitalized with a hematologic malignancy (HM).

HM patients are at a high risk of infection-related complications but are limited to antibiotic therapy based on self-reported allergies.

Beta-lactam (BL) antibiotics are a preferred treatment option for many bacterial infections, however, these antibiotics remain inaccessible as a treatment option for patients with a self-reported BL allergy. In the hospital setting, BL allergies are documented in the electronic medical record in up to 20% of hospitalized patients. Prior studies have shown that 90% of the patients for whom these allergies are reported are able to tolerate penicillin (PCN) or other BLs. Delabeling strategies to correctly identify true BL allergies in the general hospital population have proven successful. However, these studies have not been conducted among patients diagnosed with a hematological malignancy. The investigators propose to test the impact of a pharmacist-led BL allergy delabeling intervention on clinical outcomes and antibiotic use in hospitalized patients with HM.

The intervention is a multi-step PCN delabeling strategy that includes 1) an assessment of the participant's BL allergy by a clinical pharmacist based on a detailed medical history; 2) assignment of additional allergy testing based on the RENEW-IN algorithm; and 3) delabeling of the allergy within the participants electronic medical record if appropriate.

Conditions

Beta Lactam Allergy; Hematologic Malignancy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

RENEW-IN Algorithm for assessment of a beta-lactam intervention

Intervention Type: 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.

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.

Group Type: OTHER

EMR Review

Intervention Type: OTHER

Electronic medical record review for comparative analysis

Interventions

RENEW-IN Algorithm for assessment of a beta-lactam intervention

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.

Intervention Type: DIAGNOSTIC_TEST

EMR Review

Electronic medical record review for comparative analysis

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• all patients with a hematologic malignancy (including Hodgkin and non-Hodgkin lymphoma, leukemia, and myeloma) admitted to an inpatient oncology service
• reported history of a beta-lactam (BL) allergy (i.e., penicillin, cephalosporin, and/or carbapenem)

Exclusion Criteria

• patients with a history of severe cutaneous adverse reaction
• patients with a history of Stevens-Johnson syndrome
• patients with a history of toxic epidermal necrolysis
• patients with a history of drug-induced exfoliative dermatitis
• patients with a history of drug reaction with eosinophilia and systemic symptoms
• patients with a history of acute generalized exanthematous pustulosis

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Utah

OTHER

Sponsor Role: collaborator

Ebbing Lautenbach

OTHER

Sponsor Role: lead

Responsible Party

Ebbing Lautenbach

Professor of Medicine and Epidemiology

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Ebbing Lautenbach, MD,MPH,MSCE

Role: CONTACT

ebbing@pennmedicine.upenn.edu

215-898-6977

Other Identifiers

R01HS029879

Identifier Type: AHRQ

Identifier Source: secondary_id

View Link

855861

Identifier Type: -

Identifier Source: org_study_id