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

Duke University168 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

168

Conditions

Hematologic Malignancy Leukemia, Acute Neutropenia Bloodstream Infection

Interventions

No intervention.OTHER

Observational study with no intervention.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (6)

University of California San Fransisco Medical Center

San Francisco, California, United States

Hackensack Meridian Health

Nutley, New Jersey, United States

Mount Sinai Hospital

New York, New York, United States

University of North Carolina Chapel Hill

Chapel Hill, North Carolina, United States

Outcomes

Primary Outcomes

Gram-negative bloodstream infection (BSI)

Gram-negative BSI during the episode of neutropenia

Time frame: Until neutrophil recovery or 30 days after collection of the first swab in patients who do not have neutrophil recovery by 30 days

Secondary Outcomes

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

Time frame: Within 4 days after initiation of chemotherapy

Fever

Occurrence (Yes/No) of fever (≥38.0°C) during the episode of neutropenia.

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Occurs within 90 days from the collection of the first swab

Data from ClinicalTrials.gov

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