Recruiting

BL Allergy Delabeling

Sponsor:

Abramson Cancer Center at Penn Medicine

Code:

NCT07133074

Conditions

Beta Lactam Allergy

Hematologic Malignancy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

RENEW-IN Algorithm for assessment of a beta-lactam intervention

EMR Review

Study Details

Brief 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.

Conditions

Beta Lactam Allergy

Hematologic Malignancy

Study ID

NCT07133074

Start date

Apr 20, 2026

Status verified date

Jun, 2026

Completion date

Nov, 2029

Anticipated

Primary completion date

Nov, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

3800 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: Patients who enroll in the RENEW intervention

Patients who agree to actively participate in the RENEW intervention designed to identify opportunities to have the beta lactam allergy label removed from their electronic medical record.

other: Patients hospitalized with a hematologic malignancy in the time period prior to the intervention

Patients who are hospitalized with a hematologic malignancy who would meet the inclusion criteria for the intervention but who were not approached since they were hospitalized in the time period prior to introduction of the intervention. These patients will be used as a control group. Charts for these patients will be retrospectively reviewed and data will be extracted for analysis of the primary and secondary outcomes.

Interventions

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.

EMR Review

Electronic medical record review for comparative analysis

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Ebbing Lautenbach, MD,MPH,MSCE

215-898-6977ebbing@pennmedicine.upenn.edu

Locations

Hospital of the University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

More Information

Sponsor

Abramson Cancer Center at Penn Medicine

Last update posted

Jun 17, 2026

Last verified

Jun, 2026

Keywords

  • penicillin allergy
  • hematologic cancer
  • allergy delabeling

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Abramson Cancer Center at Penn Medicine on 2026-06-17.