Allergy Delabeling in Antibiotic Stewardship - Intervention
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorAbramson Cancer Center at Penn Medicine
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
RENEW-IN Algorithm for assessment of a beta-lactam intervention
Diagnostic testThe 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
Other interventionElectronic medical record review for comparative analysis
Treatment groups
3,800 Participants
are divided into 2 treatment groupsGroup A: Patients who enroll in the RENEW interventionOther 1 intervention
Group B: Patients hospitalized with a hematologic malignancy in the time period prior to the interventionOther 1 intervention
Trial outcomes
Primary outcomes
1
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 months2
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 monthsSecondary outcomes
1
Clinical Cultures positive for multi-drug resistant organisms
Proportion of participants diagnosed with multi-drug resistant organism 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 index hospitalization or death, up to 36 months2
Clinical Cultures positive for Clostridioides difficile infection
Proportion of participants diagnosed with Clostridioides difficile infection 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 index hospitalization or death, up to 36 months3
Clinical Cultures positive for Health-care Associated Infections (HAIs)
Proportion of participants diagnosed during index visit with an infection identified as related to their hospitalization, 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 months4
Need for ICU transfer
Proportion of participants admitted to the ICU during their index hospitalization, 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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Abramson Cancer Center at Penn Medicine
Lead sponsor
University of Pennsylvania
Sponsor institution
University of Utah
Collaborator
Source ClinicalTrials.gov