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| ID | Type | Description | Link |
|---|---|---|---|
| UM1AI104681 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Weill Medical College of Cornell University | OTHER |
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Induction Chemotherapy for Acute Leukemia | Receiving induction chemotherapy for acute leukemia, and receiving fluoroquinolone (FQ) prophylaxis. |
| |
| Hematopoietic stem cell transplantation (HCT) | Undergoing hematopoietic stem cell transplantation (HCT), and receiving fluoroquinolone (FQ) prophylaxis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No intervention. | Other | Observational study with no intervention. |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of and risk factors for acquiring FQRE and ESBL-E during the episode of neutropenia | Acquisition of FQRE and ESBL-E in patients not initially colonized with these organisms | During the episode of neutropenia, up to 30 days |
Inclusion Criteria:
Exclusion Criteria:
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410 adults with acute leukemia who are receiving induction chemotherapy and HCT recipients who are receiving FQ prophylaxis during neutropenia.
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| Name | Affiliation | Role |
|---|---|---|
| Michael Satlin | Weill Medical College of Cornell University | Principal Investigator |
| Vance G Fowler, MD | Duke Clinical Research Institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Fransisco Medical Center | San Francisco | California | 94143 | United States | ||
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Perianal swabs are collected from subjects and only isolates are retained. Bloodstream infection isolates are retained.
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 |
| Hackensack Meridian Health |
| Nutley |
| New Jersey |
| 07110 |
| United States |
| Mount Sinai Hospital | New York | New York | 10029 | United States |
| University of North Carolina Chapel Hill | Chapel Hill | North Carolina | 25714 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239 | United States |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| D007938 | Leukemia |
| D009503 | Neutropenia |
| D018805 | Sepsis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009370 | Neoplasms by Histologic Type |
| D000380 | Agranulocytosis |
| D007970 | Leukopenia |
| D000095542 | Cytopenia |
| D007960 | Leukocyte Disorders |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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