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

NCT04710212 | Completed

• 2 other identifiers: Pro00106363UM1AI104681
• Study Type: observational
• Target: 168
• Locations: 1 country
• Sites: 6

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Colonization with FQRE and ESBL-E

  Within 4 days after 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

• 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

• 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

• 90-day mortality

  Occurs within 90 days 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

  During the episode of neutropenia, up to 30 days

Study Arms (2)

Induction Chemotherapy for Acute Leukemia

Receiving induction chemotherapy for acute leukemia, and receiving fluoroquinolone (FQ) prophylaxis.

Other: No intervention.

Hematopoietic stem cell transplantation (HCT)

Undergoing hematopoietic stem cell transplantation (HCT), and receiving fluoroquinolone (FQ) prophylaxis.

Other: No intervention.

Interventions

No intervention. OTHER

Observational study with no intervention.

Hematopoietic stem cell transplantation (HCT); Induction Chemotherapy for Acute Leukemia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (6)

University of California San Fransisco Medical Center

San Francisco, California, 94143, United States

Location

Hackensack Meridian Health

Nutley, New Jersey, 07110, United States

Location

Mount Sinai Hospital

New York, New York, 10029, United States

Location

University of North Carolina Chapel Hill

Chapel Hill, North Carolina, 25714, United States

Location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Perianal swabs are collected from subjects and only isolates are retained. Bloodstream infection isolates are retained.

MeSH Terms

Conditions

Hematologic Neoplasms; Leukemia; Neutropenia; Sepsis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Histologic Type; Agranulocytosis; Leukopenia; Cytopenia; Leukocyte Disorders; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael Satlin

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

• Vance G Fowler, MD

  Duke Clinical Research Institute

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: January 14, 2021
• Study Start: March 12, 2021
• Primary Completion: December 30, 2021
• Study Completion: February 28, 2022
• Last Updated: April 6, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)