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Recruiting Not applicable NCT07133074

Allergy Delabeling in Antibiotic Stewardship - Intervention

No applicable phase (e.g. observational)
Conditions: Beta Lactam Allergy Hematologic Malignancy

Sponsor: Ebbing Lautenbach

trial.available_in: БГ
Overview
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.
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.
Who can participate
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
Interventions
RENEW-IN Algorithm for assessment of a beta-lactam intervention
DIAGNOSTIC_TEST
EMR Review
OTHER
Locations 1
United States (1)
Hospital of the University of Pennsylvania
Philadelphia , Pennsylvania
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
20.04.2026
Completion date
01.11.2029
Registry ID
NCT07133074
Source
clinicaltrials.gov
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