Allergy Delabeling in Antibiotic Stewardship - Intervention (RENEW-IN)

Optimizing Antibiotic Selection in Hematologic Malignancy Patients With Reported Beta-lactam Allergy - Intervention

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.

Study Overview

• Status: Recruiting
• Conditions: Hematologic Malignancy; Beta Lactam Allergy
• Intervention / Treatment: Diagnostic test: RENEW-IN Algorithm for assessment of a beta-lactam intervention; Other: EMR Review

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.

• Study Type: Interventional
• Enrollment (Estimated): 3800
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ebbing Lautenbach, MD,MPH,MSCE; Phone Number: 215-898-6977; Email: ebbing@pennmedicine.upenn.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Recruiting
      • Hospital of the University of Pennsylvania
      • Contact: Ebbing Lautenbach, MD, MPH, MSCE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Diagnostic test: 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.
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.	Other: EMR Review; Electronic medical record review for comparative analysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antibiotic Days of therapy	Proportion of participants prescribed an antibiotic during index hospitalization, from enrollment in the study to hospital discharge or death, whichever occurs first	From baseline enrollment to end of index hospitalization or death, up to 36 months
Hospital length of stay	Number of days participants are admitted to the hospital during the index visit, from enrollment in the study to hospital discharge or death, whichever occurs first	From baseline enrollment to end of index index hospitalization or death, up to 36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Cultures positive for multi-drug resistant organisms	Proportion of participants diagnosed with multi-drug resistant organism during index hospitalization, from enrollment in the study to hospital discharge or death, whichever occurs first	From baseline enrollment to end of index index hospitalization or death, up to 36 months
Clinical Cultures positive for Clostridioides difficile infection	Proportion of participants diagnosed with Clostridioides difficile infection during index hospitalization, from enrollment in the study to hospital discharge or death, whichever occurs first	From baseline enrollment to end of index index hospitalization or death, up to 36 months
Clinical Cultures positive for Health-care Associated Infections (HAIs)	Proportion of participants diagnosed during index visit with an infection identified as related to their hospitalization, from enrollment in the study to hospital discharge or death, whichever occurs first	From baseline enrollment to end of index index hospitalization or death, up to 36 months
Need for ICU transfer	Proportion of participants admitted to the ICU during their index hospitalization, from enrollment in the study to hospital discharge or death, whichever occurs first	From baseline enrollment to end of index index hospitalization or death, up to 36 months
ICU length of stay	Number of days participants are admitted to the ICU during their index hospitalization, from enrollment in the study to hospital discharge or death, whichever occurs first	From baseline enrollment to end of index index hospitalization or death, up to 36 months
Patient Disposition	Proportion of participants who are discharged from the hospital at the end of their index visit compared to the number of participants who expire during their index visit	From baseline enrollment to end of index index hospitalization or death, up to 36 months

Collaborators and Investigators

• Sponsor: Ebbing Lautenbach
• Collaborators: University of Utah

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2026
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2029

Study Registration Dates

• First Submitted: June 16, 2025
• First Submitted That Met QC Criteria: August 19, 2025
• First Posted (Actual): August 20, 2025

Study Record Updates

• Last Update Posted (Actual): April 22, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: hematologic cancer; penicillin allergy; allergy delabeling
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Hematologic Neoplasms; Anti-Bacterial Agents; Anti-Infective Agents; Lactams; beta-Lactams
• Other Study ID Numbers: 855861; R01HS029879 (U.S. AHRQ Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No