RecruitingInterventionalPhase 4

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

NCT ID: NCT07133074Sponsor: Abramson Cancer Center at Penn MedicineLast updated: 2026-06-17

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.

Arms & interventions

Diagnostic TestRENEW-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.
OtherEMR Review
Electronic medical record review for comparative analysis

Outcome measures

Primary

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

Secondary

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

Sex: AllAge: 18 Years and olderHealthy volunteers: No

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 locations (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104

Recruiting

Ebbing Lautenbach, MD, MPH, MSCE · Contact