Remove incorrect beta-lactam (penicillin and cephalosporin) allergy labels to expand antibiotic options for patients with blood cancers.
Optimizing Antibiotic Selection in Hematologic Malignancy Patients With Reported Beta-lactam Allergy - Intervention
This project tests a pharmacist-led process to remove incorrect penicillin or other beta-lactam allergy labels in hospitalized patients with blood cancers so they can receive preferred antibiotics and potentially have better outcomes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 3800 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Pennsylvania Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT07133074 on ClinicalTrials.gov |
What this trial studies
The RENEW-IN intervention uses a pharmacist-led, multi-step algorithm to review and delabel reported beta-lactam (BL) allergies among patients hospitalized with hematologic malignancies. The process includes a detailed allergy history, RENEW-IN algorithm-guided selection for additional testing, electronic medical record review, and pharmacist-directed delabeling when appropriate. The trial measures changes in antibiotic prescribing and clinical outcomes, including BL use and infection-related complications. Patients with histories of severe cutaneous adverse reactions are excluded from the intervention.
Who should consider this trial
Good fit: Hospitalized patients with a hematologic malignancy who have a documented history of a beta-lactam allergy and are admitted to the inpatient oncology service are the ideal candidates.
Not a fit: Patients with documented severe cutaneous adverse reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, DRESS, or other exclusionary severe reactions are unlikely to benefit from delabeling.
Why it matters
Potential benefit: If successful, more patients with hematologic malignancies could safely receive beta-lactam antibiotics, potentially reducing infection-related complications and improving antibiotic effectiveness.
How similar studies have performed: Prior delabeling programs in general hospitalized populations have shown that roughly 90% of reported beta-lactam allergies are not true allergies and can be safely removed, but this approach has not been well studied in patients with hematologic malignancies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Philadelphia, Pennsylvania
- Hospital of the University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: Ebbing Lautenbach, MD,MPH,MSCE
- Email: ebbing@pennmedicine.upenn.edu
- Phone: 215-898-6977
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.