This clinical trial evaluates whether the removal of beta-lactam antibiotic allergy labels from the medical records of eligible patients impacts antibiotic use and hospital length of stay in patients hospitalized for a hematologic cancer. Beta-lactam antibiotics are a class of drugs that include penicillin. Research shows that beta-lactam allergy is the most commonly listed drug allergy in the medical record. Having a penicillin allergy label is known to be associated with worse clinical outcomes for patients with cancer, as allergy labels in the medical record can prevent patients from receiving drugs in the beta-lactam family that could best treat some types of infections. Most people lose their penicillin allergy over time, so more than 90% of patients who report these allergies may not currently have a true allergy. In this trial, patients who have previously reported reactions to beta-lactam drugs undergo assessment of their current allergy status and, if eligible, may have the allergy label modified or removed from their medical record. Correctly identifying patients with and without current beta-lactam antibiotic allergies may improve patient outcomes by giving physicians making treatment decisions a broader range of antibiotics to choose from if needed.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07133074.
Locations matching your search criteria
United States
Pennsylvania
Philadelphia
University of Pennsylvania/Abramson Cancer CenterStatus: Active
Contact: Ebbing Lautenbach
Phone: 215-898-6977
PRIMARY OBJECTIVE:
I. To define the impact of the Allergy Delabeling in Antibiotic Stewardship intervention (RENEW-IN) delabeling intervention on antibiotic use and length of hospital stay among patients hospitalized with a hematologic malignancy (HM).
SECONDARY OBJECTIVE:
I. To identify the impact of the RENEW-IN delabeling intervention on multidrug-resistant organisms (MDROs), Clostridioides difficile infection (CDI), healthcare-associated infections (HAIs), need for intensive care unit (ICU) transfer, ICU days, and patient disposition (e.g., death, discharge).
OUTLINE:
Patients undergo beta-lactam allergy risk assessment by completing a questionnaire to elicit details of their allergy history. Based on assessment results, patients are assigned to a risk level and then undergo subsequent evaluations as described below. Patients with reported cephalosporin or carbapenem allergy without concurrent penicillin allergy undergo evaluation according to the Low Risk category description below.
HIGH RISK: Patients who are determined to be high risk do not undergo any further testing and do not have any changes made to the allergy label in their electronic health record (EHR).
INTERMEDIATE RISK: Patients who are determined to be intermediate risk undergo a penicillin skin prick test. If the skin prick test is positive or indeterminate, patients do not undergo any further testing and do not have any changes made to the allergy label in their EHR. If the skin prick test is negative, patients complete an oral amoxicillin challenge test. Patients receive amoxicillin orally (PO) twice, 30 minutes apart. If the oral challenge test is positive, patients do not have any changes made to the allergy label in their EHR. If the oral challenge test is negative, a recommendation is made that the patient's medical record be updated to reflect ability to take beta-lactam antibiotic if needed in the future, and the patient's EHR may be modified accordingly.
LOW RISK: Patients who are determined to be low risk or who report cephalosporin or carbapenem allergy without concurrent penicillin allergy complete an oral amoxicillin challenge test. Patients receive amoxicillin PO twice, 30 minutes apart. If the oral challenge test is positive, patients do not have any changes made to the allergy label in their EHR. If the oral challenge test is negative, a recommendation is made that the patient's medical record be updated to reflect ability to take beta-lactam antibiotic if needed in the future, and the patient's EHR may be modified accordingly. For patients with cephalosporin or carbapenem allergy without concurrent penicillin allergy who test negative, the EHR may be modified to indicate tolerance to penicillins, but cephalosporin or carbapenem allergy labels are maintained.
VERY LOW RISK: Patients who are determined to be very low risk do not require additional testing. A recommendation is made that the patient's medical record be updated to reflect ability to take beta-lactam antibiotic if needed in the future, and the patient's EHR may be modified accordingly. Patients who prefer to have clinical validation of their status may optionally undergo either the penicillin skin prick test or the oral amoxicillin challenge test, if desired.
After completion of study intervention, patients are followed for the duration of their hospital stay.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationUniversity of Pennsylvania/Abramson Cancer Center
Principal InvestigatorEbbing Lautenbach
