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NCT Number: NCT07133074

Allergy Delabeling in Antibiotic Stewardship - Intervention

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location status: Recruiting

Location contact

Ebbing Lautenbach, MD, MPH, MSCE

CONTACT

About this study

The RENEW clinical intervention is designed to evaluate the impact of a comprehensive beta lactam allergy delabeling intervention on clinical outcomes among patients hospitalized with a hematologic malignancy (HM).

HM patients are at a high risk of infection-related complications but are limited to antibiotic therapy based on self-reported allergies.

Beta-lactam (BL) antibiotics are a preferred treatment option for many bacterial infections, however, these antibiotics remain inaccessible as a treatment option for patients with a self-reported BL allergy. In the hospital setting, BL allergies are documented in the electronic medical record in up to 20% of hospitalized patients. Prior studies have shown that 90% of the patients for whom these allergies are reported are able to tolerate penicillin (PCN) or other BLs. Delabeling strategies to correctly identify true BL allergies in the general hospital population have proven successful. However, these studies have not been conducted among patients diagnosed with a hematological malignancy. The investigators propose to test the impact of a pharmacist-led BL allergy delabeling intervention on clinical outcomes and antibiotic use in hospitalized patients with HM.

The intervention is a multi-step PCN delabeling strategy that includes 1) an assessment of the participant's BL allergy by a clinical pharmacist based on a detailed medical history; 2) assignment of additional allergy testing based on the RENEW-IN algorithm; and 3) delabeling of the allergy within the participants electronic medical record if appropriate.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Diagnostic Test

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

Other

Electronic medical record review for comparative analysis

Primary outcomes

  1. Antibiotic Days of therapy

    Time frame: From baseline enrollment to end of index hospitalization or death, up to 36 months

    Proportion of participants prescribed an antibiotic during index hospitalization, from enrollment in the study to hospital discharge or death, whichever occurs first

  2. Hospital length of stay

    Time frame: From baseline enrollment to end of index index hospitalization or death, up to 36 months

    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

Secondary outcomes

  1. Clinical Cultures positive for multi-drug resistant organisms

    Time frame: From baseline enrollment to end of index index hospitalization or death, up to 36 months

    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

  2. Clinical Cultures positive for Clostridioides difficile infection

    Time frame: From baseline enrollment to end of index index hospitalization or death, up to 36 months

    Proportion of participants diagnosed with Clostridioides difficile infection during index hospitalization, from enrollment in the study to hospital discharge or death, whichever occurs first

  3. Clinical Cultures positive for Health-care Associated Infections (HAIs)

    Time frame: From baseline enrollment to end of index index hospitalization or death, up to 36 months

    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

  4. Need for ICU transfer

    Time frame: From baseline enrollment to end of index index hospitalization or death, up to 36 months

    Proportion of participants admitted to the ICU during their index hospitalization, from enrollment in the study to hospital discharge or death, whichever occurs first

  5. ICU length of stay

    Time frame: From baseline enrollment to end of index index hospitalization or death, up to 36 months

    Number of days participants are admitted to the ICU during their index hospitalization, from enrollment in the study to hospital discharge or death, whichever occurs first

  6. Patient Disposition

    Time frame: From baseline enrollment to end of index index hospitalization or death, up to 36 months

    Proportion of participants who are discharged from the hospital at the end of their index visit compared to the number of participants who expire during their index visit

Study contacts

Contact information is provided by the study sponsor or research team.

Ebbing Lautenbach, MD,MPH,MSCE

CONTACT

[email protected]

215-898-6977

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Collaborators

  • University of Utah

Registry information

Official study title

Optimizing Antibiotic Selection in Hematologic Malignancy Patients With Reported Beta-lactam Allergy - Intervention

Acronym: RENEW-IN

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Aug 20, 2025
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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