Beta Lactam Allergy in Patients With a Hematologic MalignancyRENEW-EVALNCT06967467
Allergy Delabeling in Antibiotic Stewardship - Evaluations
An observational study of Beta Lactam Allergy in Patients With a Hematologic Malignancy, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
The goal of this RENEW-EVAL project is to understand the potential barriers to implementation of the RENEW intervention into the routine clinical care of patients with a hematological malignancy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Beta Lactam Allergy in Patients With a Hematologic Malignancy
- What is being tested?
- Semi-structured interview, Survey and Ethnographic observation
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2025to Oct 2029
- Phase
- Observational
- 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
Study population: The study population includes patient participants who are admitted to an inpatient oncology service at the Hospital of the University of Pennsylvania, and clinician participants who provide clinical care during the admission. By definition, the Clinical Pharmacist who enrolls patient participants will also be part of the study population.
Who may be able to join
- Patient participants:
- a diagnosis of a hematologic malignancy (lymphoma, leukemia, myeloma)
- a prior label applied to their medical record to indicate a beta lactam allergy
- hospitalized as an inpatient to an oncology service at the time the study is conducted
- Clinician participants:
- member of the primary inpatient care team
Who cannot join
- Patient participants:
- meet one of the exclusionary criteria for the RENEW clinical intervention
- Clinician participants:
- no exclusions
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
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Optimizing Antibiotic Selection in Hematologic Malignancy Patients With Reported Beta-lactam Allergy
The goal of this RENEW-EVAL project is to understand the potential barriers to implementation of the RENEW intervention into the routine clinical care of patients with a hematological malignancy.
Read the detailed description
The RENEW clinical intervention is designed to evaluate the impact of a comprehensive beta lactam (BL) 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. The RENEW intervention will test the impact of a pharmacist-led BL allergy delabeling intervention on clinical outcomes and antibiotic use in hospitalized patients with HM.
The implementation of clinical interventions are often affected by non-clinical factors including workflow challenges and the beliefs of patients, their families, and clinical staff.
The RENEW-EVAL study is a concurrent mixed methods process evaluation of the RENEW intervention that aims to identify the social and behavioral factors that shape implementation of the intervention and to measure implementation outcomes including feasibility, acceptability, and fidelity.
Three types of data will be gathered by the research team as part of the RENEW-EVAL project: 1) semistructured interviews with patients and clinicians, (2) ethnographic observations of the delivery of the RENEW intervention, and 3) surveys assessing patient and clinician attitudes towards BL allergy delabeling, and implementation outcomes.
- Being tested
- Semi-structured interview, Survey, Ethnographic observation
- 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.
Semi-structured interviewBehavioural
Interviews designed to obtain information about patient reasons for enrolling or declining participation in the RENEW Intervention
SurveyBehavioural
Survey which will incorporate a series of closed-ended questions eliciting attitudes about the feasibility and acceptability of the intervention, allergy delabeling and future BL antibiotic use
Ethnographic observationBehavioural
Observations designed to identify communication and contextual barriers to the implementation of RENEW
SurveyBehavioural
Survey instruments will measure knowledge,attitudes, and practices surrounding allergy delabeling and antibiotic stewardship in patients with HM and perceptions of the feasibility and acceptability of the RENEW intervention
Semi-structured interviewBehavioural
Interviews designed to obtain information from clinicians about their perception of the implementation of the RENEW intervention
| Study group | Role | What they receive |
|---|---|---|
| Patients who enroll in the RENEW intervention | 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: Behavioral: Semi-structured interview; Behavioral: Survey | |
| Patients who decline enrollment in the RENEW intervention | Patients who were approached for enrollment in the RENEW intervention but declined consent. Receives: Behavioral: Semi-structured interview | |
| Clinicians | Clinicians who provide clinical care to patients enrolled in the intervention. Receives: Behavioral: Survey; Behavioral: Semi-structured interview | |
| RENEW Clinical Pharmacist | The RENEW Clinical Pharmacist will screen, recruit, and consent potential participants and perform the RENEW intervention. Receives: Behavioral: Ethnographic observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Implementation
Feasibility of implementation among clinicians and patients measured by questionnaire. Items are adapted from the validated Feasibility of Implementation Measure (FIM) and are rated on a 5-point Likert scale ranging from 1 to 5, with 1 indicating "Completely disagree" and 5 indicating "Completely agree." Higher scores indicate better feasibility. The items are analyzed individually and not summed to a total score.
Measured: From baseline Month 1 to Month 36
Acceptability of Implementation
Acceptability of implementation among clinicians and patients measured by questionnaire. Items are adapted from the validated Acceptability of Implementation Measure (AIM) and are rated on a 5-point Likert scale ranging from 1 to 5, with 1 indicating "Completely disagree" and 5 indicating "Completely agree." Higher scores indicate better acceptability. The items are analyzed individually and not summed to a total score.
Measured: From baseline Month 1 to Month 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start1 Dec 2025
- Primary completionSep 2028 (estimated)
- Study completionOct 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 Allergy in Patients With a Hematologic MalignancyStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 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
- NCT06967467
- Sponsor's protocol ID
- 02725
- Other IDs
- R01HS029879
- Acronym
- RENEW-EVAL
- Status last verified
- Jun 2026
- First submitted
- 8 Apr 2025
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 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
- ClinicalTrials.gov ID
- NCT06967467
- Acronym / sponsor ID
- RENEW-EVAL / 02725
- Keywords
- penicillin allergy, hematologic cancer, allergy delabeling
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Collaborators
- University of Utah
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 13 May 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 goal of this RENEW-EVAL project is to understand the potential barriers to implementation of the RENEW intervention into the routine clinical care of patients with a hematological malignancy.
Detailed description
The RENEW clinical intervention is designed to evaluate the impact of a comprehensive beta lactam (BL) 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. The RENEW intervention will test the impact of a pharmacist-led BL allergy delabeling intervention on clinical outcomes and antibiotic use in hospitalized patients with HM.
The implementation of clinical interventions are often affected by non-clinical factors including workflow challenges and the beliefs of patients, their families, and clinical staff.
The RENEW-EVAL study is a concurrent mixed methods process evaluation of the RENEW intervention that aims to identify the social and behavioral factors that shape implementation of the intervention and to measure implementation outcomes including feasibility, acceptability, and fidelity.
Three types of data will be gathered by the research team as part of the RENEW-EVAL project: 1) semistructured interviews with patients and clinicians, (2) ethnographic observations of the delivery of the RENEW intervention, and 3) surveys assessing patient and clinician attitudes towards BL allergy delabeling, and implementation outcomes.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patients who enroll in the RENEW intervention | – | Behavioral: Semi-structured interview, Behavioral: SurveyPatients 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 who decline enrollment in the RENEW intervention | – | Behavioral: Semi-structured interviewPatients who were approached for enrollment in the RENEW intervention but declined consent. |
| Clinicians | – | Behavioral: Survey, Behavioral: Semi-structured interviewClinicians who provide clinical care to patients enrolled in the intervention. |
| RENEW Clinical Pharmacist | – | Behavioral: Ethnographic observationThe RENEW Clinical Pharmacist will screen, recruit, and consent potential participants and perform the RENEW intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population includes patient participants who are admitted to an inpatient oncology service at the Hospital of the University of Pennsylvania, and clinician participants who provide clinical care during the admission. By definition, the Clinical Pharmacist who enrolls patient participants will also be part of the study population.
Key inclusion criteria (6 listed)
- a diagnosis of a hematologic malignancy (lymphoma, leukemia, myeloma)
- a prior label applied to their medical record to indicate a beta lactam allergy
- hospitalized as an inpatient to an oncology service at the time the study is conducted
- member of the primary inpatient care team
Key exclusion criteria (4 listed)
- meet one of the exclusionary criteria for the RENEW clinical intervention
- no exclusions
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 |
|---|---|---|
| Semi-structured interviewInterviews designed to obtain information about patient reasons for enrolling or declining participation in the RENEW Intervention | Behavioural | Patients who decline enrollment in the RENEW intervention, Patients who enroll in the RENEW intervention |
| SurveySurvey which will incorporate a series of closed-ended questions eliciting attitudes about the feasibility and acceptability of the intervention, allergy delabeling and future BL antibiotic use | Behavioural | Patients who enroll in the RENEW intervention |
| Ethnographic observationObservations designed to identify communication and contextual barriers to the implementation of RENEW | Behavioural | RENEW Clinical Pharmacist |
| SurveySurvey instruments will measure knowledge,attitudes, and practices surrounding allergy delabeling and antibiotic stewardship in patients with HM and perceptions of the feasibility and acceptability of the RENEW intervention | Behavioural | Clinicians |
| Semi-structured interviewInterviews designed to obtain information from clinicians about their perception of the implementation of the RENEW intervention | Behavioural | Clinicians |
Primary outcome
Feasibility of Implementation
Time frame: From baseline Month 1 to Month 36
Feasibility of implementation among clinicians and patients measured by questionnaire. Items are adapted from the validated Feasibility of Implementation Measure (FIM) and are rated on a 5-point Likert scale ranging from 1 to 5, with 1 indicating "Completely disagree" and 5 indicating "Completely agree." Higher scores indicate better feasibility. The items are analyzed individually and not summed to a total score.
Acceptability of Implementation
Time frame: From baseline Month 1 to Month 36
Acceptability of implementation among clinicians and patients measured by questionnaire. Items are adapted from the validated Acceptability of Implementation Measure (AIM) and are rated on a 5-point Likert scale ranging from 1 to 5, with 1 indicating "Completely disagree" and 5 indicating "Completely agree." Higher scores indicate better acceptability. The items are analyzed individually and not summed to a total score.
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 5 Jun 2026.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Beta Lactam Allergy in Patients With a 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 6 inclusion and 4 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: enrolling by invitation, as of the sponsor's last update on 5 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Implementation (time frame: From baseline Month 1 to Month 36). 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 5 Jun 2026.