Allergy Delabeling in Antibiotic Stewardship - Intervention

NCT07133074 | Recruiting Phase 4 DMC FDA Drug

• 2 other identifiers: 01725R01HS029879
• Study Type: interventional
• Target: 3,800
• Locations: 1 country
• Sites: 1

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.

Conditions

Beta Lactam Allergy; Hematologic Malignancy

Keywords

penicillin allergy; hematologic cancer; allergy delabeling

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Clinical Cultures positive for multi-drug resistant organisms

  From baseline enrollment to end of index index hospitalization or death, up to 36 months

• Clinical Cultures positive for Clostridioides difficile infection

  From baseline enrollment to end of index index hospitalization or death, up to 36 months

• Clinical Cultures positive for Health-care Associated Infections (HAIs)

  From baseline enrollment to end of index index hospitalization or death, up to 36 months

• Need for ICU transfer

  From baseline enrollment to end of index index hospitalization or death, up to 36 months

• ICU length of stay

  From baseline enrollment to end of index index hospitalization or death, up to 36 months

Study Arms (2)

Patients who enroll in the RENEW intervention

OTHER

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

Patients hospitalized with a hematologic malignancy in the time period prior to the intervention

OTHER

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

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.

Patients who enroll in the RENEW intervention

EMR Review OTHER

Electronic medical record review for comparative analysis

Patients hospitalized with a hematologic malignancy in the time period prior to the intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Utah: collaborator
• Abramson Cancer Center at Penn Medicine: lead

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Ebbing Lautenbach, MD,MPH,MSCE

CONTACT

215-898-6977; ebbing@pennmedicine.upenn.edu

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine and Epidemiology

Model Details: Interrupted Time Series Analysis

Study Record Dates

• First Submitted: June 16, 2025
• First Posted: August 20, 2025
• Study Start: April 20, 2026
• Primary Completion (Estimated): November 1, 2028
• Study Completion (Estimated): November 1, 2029
• Last Updated: June 17, 2026

Record last verified: 2026-06

Locations

US (1)