3800 Participants NeededMy employer runs this trial

Allergy Delabeling for Blood Cancers

(RENEW-IN Trial)

EL
Overseen ByEbbing Lautenbach, MD,MPH,MSCE
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Ebbing Lautenbach
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method, the RENEW-IN Algorithm, to remove incorrect allergy labels from the medical records of patients with blood cancers, such as leukemia and lymphoma, who have been labeled allergic to certain antibiotics. The goal is to determine if correcting these records can improve antibiotic use and overall health outcomes. The trial includes two groups: one participates in the new method, while the other serves as a comparison by reviewing past records. It seeks patients hospitalized with blood cancers who have been labeled allergic to antibiotics like penicillin. As an unphased trial, this study offers patients the chance to contribute to innovative research that could enhance antibiotic use and health outcomes for others with similar conditions.

What prior data suggests that the RENEW-IN Algorithm is safe for patients with hematologic malignancies?

Research has shown that the RENEW-IN method, used to remove incorrect allergy labels, is generally safe for patients. In one study, researchers checked 59 patients, with amoxicillin being the most commonly reported allergy. The results indicated that a rash was the most frequent reaction, but no serious side effects occurred.

Another review found that 9% of patients experienced mild intolerance, while 55% were considered low-risk, likely having mild or no reactions. This suggests that removing incorrect allergy labels is mostly well-tolerated.

Overall, these studies indicate that the RENEW-IN method is safe, with only a small percentage of patients experiencing mild intolerance. This approach is particularly important for patients treated for blood cancers, as it can help them safely use necessary antibiotics.12345

Why are researchers excited about this trial?

Researchers are excited about the RENEW-IN Algorithm because it offers a novel approach to allergy delabeling in patients with blood cancers. Unlike standard treatments, which often focus on managing allergic reactions, the RENEW-IN Algorithm actively identifies opportunities to remove incorrect beta-lactam allergy labels from patients' medical records. This approach could significantly improve treatment options for patients by allowing them access to more effective antibiotics, potentially reducing complications and enhancing overall care.

What evidence suggests that the RENEW-IN Algorithm is effective for allergy delabeling in blood cancer patients?

Research shows that removing a beta-lactam allergy label can improve treatment for patients with blood cancers. In past studies, patients labeled with beta-lactam allergies needed more antibiotics and faced higher risks of infections and hospital readmissions. Removing the allergy label reduced these risks. For instance, one study found that after assessments, 9% of patients had their allergy label removed, improving antibiotic use. In this trial, participants enrolling in the RENEW intervention will undergo assessment with the RENEW-IN Algorithm, which could enhance antibiotic treatment and health outcomes for these patients.12346

Are You a Good Fit for This Trial?

Inclusion Criteria

Reported history of a beta-lactam (BL) allergy (i.e., penicillin, cephalosporin, and/or carbapenem)
I have a blood cancer and am admitted to the hospital for treatment.

Exclusion Criteria

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
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Pharmacist-led beta-lactam allergy delabeling intervention including assessment, testing, and potential delabeling

Up to 36 months
Ongoing hospital visits as needed

Follow-up

Participants are monitored for clinical outcomes and antibiotic use after intervention

Up to 36 months

What Are the Treatments Tested in This Trial?

Interventions

  • RENEW-IN Algorithm

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Patients who enroll in the RENEW interventionExperimental Treatment1 Intervention
Group II: Patients hospitalized with a hematologic malignancy in the time period prior to the interventionExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ebbing Lautenbach

Lead Sponsor

University of Utah

Collaborator

Trials
1,169
Recruited
1,623,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38907094

Implementation and outcomes of beta-lactam allergy ...

441 assessments in 377 patients (median 63 years-old, 41% male, 50% hematological cancer) met inclusion criteria. The assessments revealed 9% ...

Allergy Delabeling in Antibiotic Stewardship - Intervention

... delabeling intervention on antibiotic use and clinical outcomes in patients with a hematologic malignancy ... Algorithm for assessment of a beta-lactam ...

De-Labeling Beta-Lactam Allergies in Haematology/ ...

The Impact of Reported Beta-Lactam Allergy in. Hospitalized Patients With Hematologic Malignancies Requiring Antibiotics. Clin Infect Dis. 2018. Jun 18;67(1): ...

Penicillin allergy evaluation in hospitalized patients ... - PMC

Inpatients with hematologic malignancy and β-lactam allergy have increased antibiotic use and mortality risk, higher infection and readmission rates, and longer ...

Allergy Delabeling in Antibiotic Stewardship - Evaluations

... RENEW intervention into the routine clinical care of patients ... outcomes among patients hospitalized with a hematologic malignancy (HM).

Approach for delabeling beta-lactam allergy in children

In this review, we will discuss the impact of the label of BL allergy and the role of the different tools currently available to efficiently address BL allergy ...