Actively Recruiting
Optimizing Antibiotic Selection in Hematologic Malignancy Patients With Reported Beta-lactam Allergy - Intervention
Led by Ebbing Lautenbach · Updated on 2026-04-22
3800
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
E
Ebbing Lautenbach
Lead Sponsor
U
University of Utah
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of a beta-lactam allergy delabeling intervention on antibiotic use and clinical outcomes in patients hospitalized with hematologic malignancies, such as lymphoma, leukemia, and myeloma. These patients often face infection risks but may avoid preferred beta-lactam antibiotics due to self-reported allergies. The study aims to assess if removing incorrect allergy labels can improve treatment options and clinical outcomes. The intervention involves a multi-step approach led by clinical pharmacists, starting with a detailed allergy history assessment using the RENEW-IN algorithm. Based on this assessment, additional allergy testing may be assigned, and if appropriate, the beta-lactam allergy label is removed from the patient's electronic medical record. The study compares patients who participate in this intervention with a control group of patients hospitalized before the intervention was introduced, whose records are reviewed retrospectively. Participants will be monitored from enrollment until the end of their hospitalization or death, for up to 36 months. Researchers will track antibiotic days of therapy, hospital length of stay, infections caused by resistant organisms, need for ICU transfer, ICU stay duration, and patient outcomes. Data collection involves electronic medical record review and clinical assessments to evaluate the impact of allergy delabeling on treatment and health status.
CONDITIONS
Brief Title
Allergy Delabeling in Antibiotic Stewardship - Intervention
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 allergy such as penicillin, cephalosporin, or carbapenem
- Adults aged 18 years or older
You will not qualify if you...
- History of severe cutaneous adverse reactions
- History of Stevens-Johnson syndrome
- History of toxic epidermal necrolysis
- History of drug-induced exfoliative dermatitis
- History of drug reaction with eosinophilia and systemic symptoms
- History of acute generalized exanthematous pustulosis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to the duration of the index hospitalization
Participants undergo a pharmacist-led beta-lactam allergy assessment using the RENEW-IN algorithm, including detailed allergy history and possible allergy delabeling in their electronic medical record.
1 assessment visit during hospitalization
Duration - Up to 36 months from enrollment
Participants are monitored for clinical outcomes such as antibiotic use, hospital length of stay, and infection-related events until discharge or death.
Monitoring through medical record review without additional visits
Trial Site Locations
Total: 1 location
1
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
E
Ebbing Lautenbach, MD,MPH,MSCE
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
2
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