Beta Lactam AllergyPhase 4RENEW-INNCT07133074
Allergy Delabeling in Antibiotic Stewardship - Intervention
A Phase 4 study testing RENEW-IN Algorithm for assessment of a beta-lactam intervention and EMR Review in people with Beta Lactam Allergy and Hematologic Malignancy, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Beta Lactam Allergy, Hematologic Malignancy
- What is being tested?
- RENEW-IN Algorithm for assessment of a beta-lactam intervention and EMR Review
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,800 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2026to Nov 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Ebbing Lautenbach, MD, MPH, MSCE
About this study
Official title: Optimizing Antibiotic Selection in Hematologic Malignancy Patients With Reported Beta-lactam Allergy - 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.
Read the detailed description
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.
- Conditions
- Beta Lactam Allergy, Hematologic Malignancy
- Being tested
- RENEW-IN Algorithm for assessment of a beta-lactam intervention, EMR Review
- Keywords
- penicillin allergy, hematologic cancer, allergy delabeling
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RENEW-IN Algorithm for assessment of a beta-lactam interventionDiagnostic 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 ReviewOther
Electronic medical record review for comparative analysis
| Study group | Role | What they receive |
|---|---|---|
| Patients who enroll in the RENEW intervention | Other | 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. Receives: Diagnostic Test: RENEW-IN Algorithm for assessment of a beta-lactam intervention |
| Patients hospitalized with a hematologic malignancy in the time period prior to the intervention | Other | 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. Receives: Other: EMR Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From baseline enrollment to end of index hospitalization or death, up to 36 months
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
Measured: From baseline enrollment to end of index index hospitalization or death, up to 36 months
Secondary outcomes (6)
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
Measured: From baseline enrollment to end of index index hospitalization or death, up to 36 months
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
Measured: From baseline enrollment to end of index index hospitalization or death, up to 36 months
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
Measured: From baseline enrollment to end of index index hospitalization or death, up to 36 months
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
Measured: From baseline enrollment to end of index index hospitalization or death, up to 36 months
ICU length of stay
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
Measured: From baseline enrollment to end of index index hospitalization or death, up to 36 months
Patient Disposition
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
Measured: From baseline enrollment to end of index index hospitalization or death, up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start20 Apr 2026
- Primary completionNov 2028 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Beta Lactam AllergyStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Interrupted Time Series Analysis
- Masking
- None (open label)
- Enrolment
- 3,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Utah
- Responsible party
- Principal investigator, Ebbing Lautenbach, MD, MPH, MSCE, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07133074
- Sponsor's protocol ID
- 01725
- Other IDs
- R01HS029879
- Acronym
- RENEW-IN
- Status last verified
- Jun 2026
- First submitted
- 16 Jun 2025
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Antibiotic Selection in Hematologic Malignancy Patients With Reported Beta-lactam Allergy - Intervention
- ClinicalTrials.gov ID
- NCT07133074
- Acronym / sponsor ID
- RENEW-IN / 01725
- Conditions
- Beta Lactam Allergy, Hematologic Malignancy
- Keywords
- penicillin allergy, hematologic cancer, allergy delabeling
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 3,800 participants (estimated)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Collaborators
- University of Utah
- Study start
- 20 Apr 2026 (actual)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 20 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Interrupted Time Series Analysis
| Arm | Type | Receives |
|---|---|---|
| Patients who enroll in the RENEW intervention | Other | Diagnostic Test: RENEW-IN Algorithm for assessment of a beta-lactam interventionPatients 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. |
| Patients hospitalized with a hematologic malignancy in the time period prior to the intervention | Other | Other: EMR ReviewPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RENEW-IN Algorithm for assessment of a beta-lactam interventionThe RENEW-IN intervention includes a detailed assessment of the participant's beta-lactam allergy history and determination of a risk-level for allergy-delabeling. | Diagnostic test | Patients who enroll in the RENEW intervention |
| EMR ReviewElectronic medical record review for comparative analysis | Other | Patients hospitalized with a hematologic malignancy in the time period prior to the intervention |
Primary outcome
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
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
6 secondary outcomes
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
Clinical Cultures positive for Clostridioides difficile infection
Time frame: From baseline enrollment to end of index index hospitalization or death, up to 36 months
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
Need for ICU transfer
Time frame: From baseline enrollment to end of index index hospitalization or death, up to 36 months
ICU length of stay
Time frame: From baseline enrollment to end of index index hospitalization or death, up to 36 months
Patient Disposition
Time frame: From baseline enrollment to end of index index hospitalization or death, up to 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing RENEW-IN Algorithm for assessment of a beta-lactam intervention and EMR Review in people with Beta Lactam Allergy and Hematologic Malignancy, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ebbing Lautenbach, MD,MPH,MSCE (215-898-6977, ebbing@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Antibiotic Days of therapy (time frame: From baseline enrollment to end of index hospitalization or death, up to 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.