Screening for Colonization With Resistant Enterobacterales in Neutropenic Patients With Hematologic Malignancies

Study Overview
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Brief Summary
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This is a prospective, observational cohort study to assess the frequency with which neutropenic patients with hematologic malignancies and hematopoietic cell transplant (HCT) recipients are colonized with fluoroquinolone-resistant Enterobacterales (FQRE) and the clinical impact of FQRE colonization.

Detailed Description
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This is a prospective, observational cohort study to assess the frequency with which neutropenic patients with hematologic malignancies and hematopoietic cell transplant (HCT) recipients are colonized with fluoroquinolone-resistant Enterobacterales (FQRE) and the clinical impact of FQRE colonization. The investigator will collect perianal swabs from patients receiving induction chemotherapy for acute leukemia or undergoing hematopoietic stem cell transplantation (HCT), and who are receiving fluoroquinolone (FQ) prophylaxis. FQRE colonization will be assessed by culture, and the investigator will correlate FQRE colonization with the risk of Gram-negative bacteremia during neutropenia. Population: 410 adults with acute leukemia who are receiving induction chemotherapy and HCT recipients who are receiving FQ prophylaxis during neutropenia. Results of this study will be combined with a portion of subject data from an identically-designed R01-funded study of FQRE colonization. The combined data will be used for study analysis and reporting.

Official Title
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Screening for Colonization With Resistant Enterobacterales in Neutropenic Patients With Hematologic Malignancies (SCENE)

Conditions
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Leukemia, Acute, Hematologic Malignancy, Neutropenia, Bloodstream Infection

Intervention / Treatment
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* Other: No intervention.


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Ability to provide informed consent Male or female ≥18 years of age Receiving intensive induction chemotherapy for acute leukemia or undergoing HCT Receive fluoroquinolone prophylaxis during neutropenia Exclusion Criteria: Expected to have <7 days of neutropenia (absolute neutrophil count ≤500 cells/μL) after receipt of chemotherapy (a) (acute leukemia cohort only) First swab collected ≥5 days after onset of chemotherapy First swab collected after the day of transplant (HCT cohort only) Acute promyelocytic leukemia Receiving chimeric antigen receptor (CAR)-T-cell therapy Pregnant women as determined by clinician

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Induction Chemotherapy for Acute Leukemia<br>Receiving induction chemotherapy for acute leukemia, and receiving fluoroquinolone (FQ) prophylaxis. | Other: No intervention.<br>* Observational study with no intervention.<br>|
| Hematopoietic stem cell transplantation (HCT)<br>Undergoing hematopoietic stem cell transplantation (HCT), and receiving fluoroquinolone (FQ) prophylaxis. | Other: No intervention.<br>* Observational study with no intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gram-negative bloodstream infection (BSI) | Gram-negative BSI during the episode of neutropenia | Until neutrophil recovery or 30 days after collection of the first swab in patients who do not have neutrophil recovery by 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Colonization with FQRE and ESBL-E | Colonization with fluoroquinolone-resistant Enterobacterales (FQRE) and Extended-spectrum-beta-lactamase-producing Enterobacterales (ESBL-E) upon initiation of chemotherapy | Within 4 days after initiation of chemotherapy | 
| Fever | Occurrence (Yes/No) of fever (≥38.0°C) during the episode of neutropenia. | Until neutrophil recovery or 30 days after collection of the first swab in patients who do not have neutrophil recovery by 30 days | 
| Bloodstream infection (BSI) | Any BSI during the episode of neutropenia | Until neutrophil recovery or 30 days after collection of the first swab in patients who do not have neutrophil recovery by 30 days | 
| Intensive care unit (ICU) admission | Intensive care unit admission prior to recovery from neutropenia | Prior to neutrophil recovery or 30 days after collection of the first swab in patients who do not have neutrophil recovery by 30 days | 
| 90-day mortality | 90-day mortality from the collection of the first swab | Occurs within 90 days from the collection of the first swab | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HCT, Induction chemotherapy, FQRE, Fluoroquinolone-resistant Enterobacterales, Hematopoietic stem cell transplantation, Hematologic Malignancy, Acute Leukemia, Neutropenia, Bloodstream infection, Perianal swab, Gram-negative bacteremia