SCENE: Screening for Colonization With Resistant Enterobacterales in Neutropenic Patients With Hematologic Malignancies
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Induction Chemotherapy for Acute Leukemia Receiving induction chemotherapy for acute leukemia, and receiving fluoroquinolone (FQ) prophylaxis. |
Other: No intervention.
Observational study with no intervention.
|
| Hematopoietic stem cell transplantation (HCT) Undergoing hematopoietic stem cell transplantation (HCT), and receiving fluoroquinolone (FQ) prophylaxis. |
Other: No intervention.
Observational study with no intervention.
|
Outcome Measures
Primary Outcome Measures
- Gram-negative bloodstream infection (BSI) [Until neutrophil recovery or 30 days after collection of the first swab in patients who do not have neutrophil recovery by 30 days]
Gram-negative BSI during the episode of neutropenia
Secondary Outcome Measures
- Colonization with FQRE and ESBL-E [Within 4 days after initiation of chemotherapy]
Colonization with fluoroquinolone-resistant Enterobacterales (FQRE) and Extended-spectrum-beta-lactamase-producing Enterobacterales (ESBL-E) upon initiation of chemotherapy
- Fever [Until neutrophil recovery or 30 days after collection of the first swab in patients who do not have neutrophil recovery by 30 days]
Occurrence (Yes/No) of fever (≥38.0°C) during the episode of neutropenia.
- Bloodstream infection (BSI) [Until neutrophil recovery or 30 days after collection of the first swab in patients who do not have neutrophil recovery by 30 days]
Any BSI during the episode of neutropenia
- Intensive care unit (ICU) admission [Prior to 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 admission prior to recovery from neutropenia
- 90-day mortality [Occurs within 90 days from the collection of the first swab]
90-day mortality from the collection of the first swab
Other Outcome Measures
- Incidence of and risk factors for acquiring FQRE and ESBL-E during the episode of neutropenia [During the episode of neutropenia, up to 30 days]
Acquisition of FQRE and ESBL-E in patients not initially colonized with these organisms
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Ability to provide informed consent
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Male or female ≥18 years of age
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Receiving intensive induction chemotherapy for acute leukemia or undergoing HCT
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Receive fluoroquinolone prophylaxis during neutropenia
Exclusion Criteria:
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Expected to have <7 days of neutropenia (absolute neutrophil count ≤500 cells/μL) after receipt of chemotherapy (a) (acute leukemia cohort only)
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First swab collected ≥5 days after onset of chemotherapy
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First swab collected after the day of transplant (HCT cohort only)
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Acute promyelocytic leukemia
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Receiving chimeric antigen receptor (CAR)-T-cell therapy
-
Pregnant women as determined by clinician
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of California San Fransisco Medical Center | San Francisco | California | United States | 94143 |
| 2 | Hackensack Meridian Health | Nutley | New Jersey | United States | 07110 |
| 3 | Mount Sinai Hospital | New York | New York | United States | 10029 |
| 4 | University of North Carolina Chapel Hill | Chapel Hill | North Carolina | United States | 25714 |
| 5 | Oregon Health and Science University | Portland | Oregon | United States | 97239 |
| 6 | University of Pittsburgh | Pittsburgh | Pennsylvania | United States | 15213 |
Sponsors and Collaborators
- Duke University
- Weill Medical College of Cornell University
- National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
- Principal Investigator: Michael Satlin, Weill Medical College of Cornell University
- Study Director: Vance G Fowler, MD, Duke Clinical Research Institute
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Pro00106363
- UM1AI104681