Clinical trial NCT04710212: Screening for Colonization With Resistant Enterobacterales in Neutropenic Patients With Hematologic Malignancies
Official title: Screening for Colonization With Resistant Enterobacterales in Neutropenic Patients With Hematologic Malignancies (SCENE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hematologic Malignancy
Leukemia, Acute
Neutropenia
Bloodstream Infection
Keywords: FQRE
Fluoroquinolone-resistant Enterobacterales
Hematopoietic stem cell transplantation
HCT
Induction chemotherapy
Hematologic Malignancy
Acute Leukemia
Neutropenia
Bloodstream infection
Perianal swab
Gram-negative bacteremia
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: Weill Medical College of Cornell University
name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2021-01-14
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 410 adults with acute leukemia who are receiving induction chemotherapy and HCT recipients who are receiving FQ prophylaxis during neutropenia.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Gram-negative bloodstream infection (BSI)
timeFrame: 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:
measure: Colonization with FQRE and ESBL-E
timeFrame: Within 4 days after initiation of chemotherapy
measure: Fever
timeFrame: Until neutrophil recovery or 30 days after collection of the first swab in patients who do not have neutrophil recovery by 30 days
measure: Bloodstream infection (BSI)
timeFrame: Until neutrophil recovery or 30 days after collection of the first swab in patients who do not have neutrophil recovery by 30 days
measure: Intensive care unit (ICU) admission
timeFrame: Prior to neutrophil recovery or 30 days after collection of the first swab in patients who do not have neutrophil recovery by 30 days
measure: 90-day mortality
timeFrame: Occurs within 90 days from the collection of the first swab
Other outcomes:
measure: Incidence of and risk factors for acquiring FQRE and ESBL-E during the episode of neutropenia
timeFrame: During the episode of neutropenia, up to 30 days
Locations:
city: San Francisco
country: United States
facility: University of California San Fransisco Medical Center
state: California
city: Nutley
country: United States
facility: Hackensack Meridian Health
state: New Jersey
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina Chapel Hill
state: North Carolina
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: Weill Medical College of Cornell University
name: Michael Satlin
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke Clinical Research Institute
name: Vance G Fowler, MD
role: STUDY_DIRECTOR
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