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Completed

NCT Number: NCT04710212

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

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.

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Key information

Conditions

Hematologic Malignancy Agranulocytosis Bloodstream Infection Cytopenia Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Infections Inflammation Leukemia Leukemia, Acute Leukocyte Disorders Leukopenia Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neutropenia Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California San Fransisco Medical Center, San Francisco, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ability to provide informed consent
  • Male or female ≥18 years of age
  • Receiving intensive induction chemotherapy for acute leukemia or undergoing HCT
  • Receive fluoroquinolone prophylaxis during neutropenia

Exclusion criteria

  • Expected to have <7 days of neutropenia (absolute neutrophil count ≤500 cells/μL) after receipt of chemotherapy (a) (acute leukemia cohort only)
  • First swab collected ≥5 days after onset of chemotherapy
  • First swab collected after the day of transplant (HCT cohort only)
  • Acute promyelocytic leukemia
  • Receiving chimeric antigen receptor (CAR)-T-cell therapy
  • Pregnant women as determined by clinician

Treatment and study plan

No intervention.

Other

Observational study with no intervention.

Primary outcomes

  1. Gram-negative bloodstream infection (BSI)

    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

    Gram-negative BSI during the episode of neutropenia

Secondary outcomes

  1. Colonization with FQRE and ESBL-E

    Time frame: 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

  2. Fever

    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

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

  3. Bloodstream infection (BSI)

    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

    Any BSI during the episode of neutropenia

  4. Intensive care unit (ICU) admission

    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

    Intensive care unit admission prior to recovery from neutropenia

  5. 90-day mortality

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

    90-day mortality from the collection of the first swab

Other outcomes

  1. Incidence of and risk factors for acquiring FQRE and ESBL-E during the episode of neutropenia

    Time frame: During the episode of neutropenia, up to 30 days

    Acquisition of FQRE and ESBL-E in patients not initially colonized with these organisms

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)
  • Weill Medical College of Cornell University

Registry information

Official study title

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

Acronym: SCENE

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Jan 14, 2021
Registry last updated
Apr 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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