Allergy Delabeling in Antibiotic Stewardship - Intervention
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: RENEW-IN Algorithm for assessment of a beta-lactam intervention, EMR Review.
- Who it may be relevant to
- Registry conditions: Beta Lactam Allergy, Hematologic Malignancy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Optimizing Antibiotic Selection in Hematologic Malignancy Patients With Reported Beta-lactam Allergy - Intervention
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.
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.
Interventions
- 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
Primary outcome measures
- Antibiotic Days of therapy [Time frame: From baseline enrollment to end of index hospitalization or death, up to 36 months]
- Hospital length of stay [Time frame: From baseline enrollment to end of index index hospitalization or death, up to 36 months]
Secondary outcome measures (6)
- Clinical Cultures positive for multi-drug resistant organisms [Time frame: From baseline enrollment to end of index index hospitalization or death, up to 36 months]
- Clinical Cultures positive for Clostridioides difficile infection [Time frame: From baseline enrollment to end of index index hospitalization or death, up to 36 months]
- Clinical Cultures positive for Health-care Associated Infections (HAIs) [Time frame: From baseline enrollment to end of index index hospitalization or death, up to 36 months]
- Need for ICU transfer [Time frame: From baseline enrollment to end of index index hospitalization or death, up to 36 months]
- ICU length of stay [Time frame: From baseline enrollment to end of index index hospitalization or death, up to 36 months]
- Patient Disposition [Time frame: From baseline enrollment to end of index index hospitalization or death, up to 36 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- Hospital of the University of Pennsylvania — Philadelphia
Identifiers
NCT: NCT07133074 · 01725 · R01HS029879