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

Completed

• Conditions: Leukemia, Acute; Hematologic Malignancy; Neutropenia; Bloodstream Infection
• Interventions: Other: No intervention.

• Registration Number: NCT04710212
• Lead Sponsor: Duke University

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2021-01-11
• Study First Submitted QC: 2021-01-13
• Study First Posted: 2021-01-14
• Study Start: 2021-03-12
• Primary Completion: 2021-12-30
• Study Completion: 2022-02-28
• Status Verified: 2022-03
• Last Update Submitted: 2022-04-05
• Last Update Posted: 2022-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 168

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

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hematopoietic stem cell transplantation (HCT)	No intervention.	Undergoing hematopoietic stem cell transplantation (HCT), and receiving fluoroquinolone (FQ) prophylaxis.
Induction Chemotherapy for Acute Leukemia	No intervention.	Receiving induction chemotherapy for acute leukemia, and receiving fluoroquinolone (FQ) prophylaxis.

Primary Outcome Measures

Name	Time	Method
Gram-negative 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	Gram-negative BSI during the episode of neutropenia

Secondary Outcome Measures

Name	Time	Method
Colonization with FQRE and ESBL-E	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
90-day mortality	Occurs within 90 days from the collection of the first swab	90-day mortality from the collection of the first swab
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	Any BSI during the episode of neutropenia
Fever	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.
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	Intensive care unit admission prior to recovery from neutropenia

Trial Locations

Locations (6)

Mount Sinai Hospital; 🇺🇸 New York, New York, United States

University of California San Fransisco Medical Center; 🇺🇸 San Francisco, California, United States

University of North Carolina Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

Hackensack Meridian Health; 🇺🇸 Nutley, New Jersey, United States