Allergy Delabeling in Antibiotic Stewardship - Intervention

Not Applicable

Not yet recruiting

• Conditions: Beta Lactam Allergy; Hematologic Malignancy

• Registration Number: NCT07133074
• Lead Sponsor: Ebbing Lautenbach

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.

Study Timeline

• Study First Submitted: 2025-06-16
• Status Verified: 2025-08
• Study First Submitted QC: 2025-08-19
• Last Update Submitted: 2025-08-19
• Study First Posted: 2025-08-20
• Last Update Posted: 2025-08-20
• Study Start: 2025-11-01
• Primary Completion: 2028-11
• Study Completion: 2029-11-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 3800

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Hospital length of stay	From baseline enrollment to end of index index hospitalization or death, up to 36 months	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
Antibiotic Days of therapy	From baseline enrollment to end of index hospitalization or death, up to 36 months	Proportion of participants prescribed an antibiotic during index hospitalization, from enrollment in the study to hospital discharge or death, whichever occurs first

Secondary Outcome Measures

Name	Time	Method
Clinical Cultures positive for multi-drug resistant organisms	From baseline enrollment to end of index index hospitalization or death, up to 36 months	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
Clinical Cultures positive for Clostridioides difficile infection	From baseline enrollment to end of index index hospitalization or death, up to 36 months	Proportion of participants diagnosed with Clostridioides difficile infection during index hospitalization, from enrollment in the study to hospital discharge or death, whichever occurs first
Clinical Cultures positive for Health-care Associated Infections (HAIs)	From baseline enrollment to end of index index hospitalization or death, up to 36 months	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
Need for ICU transfer	From baseline enrollment to end of index index hospitalization or death, up to 36 months	Proportion of participants admitted to the ICU during their index hospitalization, from enrollment in the study to hospital discharge or death, whichever occurs first
ICU length of stay	From baseline enrollment to end of index index hospitalization or death, up to 36 months	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
Patient Disposition	From baseline enrollment to end of index index hospitalization or death, up to 36 months	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