NCT07133074

Allergy Delabeling in Antibiotic Stewardship - Intervention

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,800 (estimated)
• Sponsor: Ebbing Lautenbach · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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	EMR Review	Electronic medical record review for comparative analysis

Timeline

• Start date: 2026-05-01
• Primary completion: 2028-11-01
• Completion: 2029-11-01
• First posted: 2025-08-20
• Last updated: 2026-04-13