Bloodstream Infection, Hematologic Malignancy, Leukemia, Acute, Neutropenia
Conditions
Keywords
FQRE, Fluoroquinolone-resistant Enterobacterales, Hematopoietic stem cell transplantation, HCT, Induction chemotherapy, Hematologic Malignancy, Acute Leukemia, Neutropenia, Bloodstream infection, Perianal swab, Gram-negative bacteremia
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.
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.
Interventions
OTHERNo intervention.
Observational study with no intervention.
Sponsors
Weill Medical College of Cornell University
National Institute of Allergy and Infectious Diseases (NIAID)
Duke University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Ability to provide informed consent 2. Male or female ≥18 years of age 3. Receiving intensive induction chemotherapy for acute leukemia or undergoing HCT 4. Receive fluoroquinolone prophylaxis during neutropenia
Exclusion criteria
1. Expected to have \<7 days of neutropenia (absolute neutrophil count ≤500 cells/μL) after receipt of chemotherapy (a) (acute leukemia cohort only) 2. First swab collected ≥5 days after onset of chemotherapy 3. First swab collected after the day of transplant (HCT cohort only) 4. Acute promyelocytic leukemia 5. Receiving chimeric antigen receptor (CAR)-T-cell therapy 6. Pregnant women as determined by clinician
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Outcome results
None listed