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

Ebbing Lautenbach

Status: Not yet enrolling

Conditions: Hematologic Malignancy; Beta Lactam Allergy

Treatments: Diagnostic Test: RENEW-IN Algorithm for assessment of a beta-lactam intervention; Other: EMR Review

Study type: Interventional

Funder types: Other

Identifiers

NCT07133074

R01HS029879 (U.S. AHRQ Grant/Contract)

855861

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,800 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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3,800 participants in 2 patient groups

Patients who enroll in the RENEW intervention

Other group

Description:

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.

Treatment:

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 group

Description:

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.

Treatment:

Other: EMR Review