Screening for Colonization With Resistant Enterobacterales in Neutropenic Patients With Hematologic Malignancies (SCENE)

Screening for Colonization With Resistant Enterobacterales in Neutropenic Patients With Hematologic Malignancies (SCENE)

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.

Study Overview

• Status: Completed
• Conditions: Neutropenia; Hematologic Malignancy; Bloodstream Infection; Leukemia, Acute
• Intervention / Treatment: Other: No intervention.

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 Type: Observational
• Enrollment (Actual): 168

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California San Fransisco Medical Center
  • New Jersey
    • Nutley, New Jersey, United States, 07110
      • Hackensack Meridian Health
  • New York
    • New York, New York, United States, 10029
      • Mount Sinai Hospital
  • North Carolina
    • Chapel Hill, North Carolina, United States, 25714
      • University of North Carolina Chapel Hill
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health and Science University
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID); Weill Medical College of Cornell University
• Investigators: Principal Investigator: Michael Satlin, Weill Medical College of Cornell University; Study Director: Vance G Fowler, MD, Duke Clinical Research Institute

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 12, 2021
• Primary Completion (ACTUAL): December 30, 2021
• Study Completion (ACTUAL): February 28, 2022

Study Registration Dates

• First Submitted: January 11, 2021
• First Submitted That Met QC Criteria: January 13, 2021
• First Posted (ACTUAL): January 14, 2021

Study Record Updates

• Last Update Posted (ACTUAL): April 6, 2022
• Last Update Submitted That Met QC Criteria: April 5, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: HCT; Hematologic Malignancy; Hematopoietic stem cell transplantation; Bloodstream infection; Neutropenia; Acute Leukemia; Induction chemotherapy; Gram-negative bacteremia; FQRE; Fluoroquinolone-resistant Enterobacterales; Perianal swab
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Neoplasms by Site; Systemic Inflammatory Response Syndrome; Inflammation; Hematologic Diseases; Agranulocytosis; Leukopenia; Leukocyte Disorders; Neoplasms; Sepsis; Hematologic Neoplasms; Neutropenia
• Other Study ID Numbers: Pro00106363; UM1AI104681 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No