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

Hematologic Malignancy Clinical Trial

— SCENE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04710212
• Other study ID #: Pro00106363
• Secondary ID: UM1AI104681
• Status: Completed
• Start date: March 12, 2021
• Est. completion date: February 28, 2022

Study information

• Verified date: March 2022
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: February 28, 2022
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bloodstream Infection
• Hematologic Malignancy
• Hematologic Neoplasms
• Leukemia, Acute
• Neoplasms
• Neutropenia
• Sepsis

Intervention

Other:
• No intervention.
Observational study with no intervention.

Locations

Country	Name	City	State
United States	University of North Carolina Chapel Hill	Chapel Hill	North Carolina
United States	Mount Sinai Hospital	New York	New York
United States	Hackensack Meridian Health	Nutley	New Jersey
United States	University of Pittsburgh	Pittsburgh	Pennsylvania
United States	Oregon Health and Science University	Portland	Oregon
United States	University of California San Fransisco Medical Center	San Francisco	California

Sponsors (3)

Lead Sponsor	Collaborator
Duke University	National Institute of Allergy and Infectious Diseases (NIAID), Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	90-day mortality	90-day mortality from the collection of the first swab	Occurs within 90 days from the collection of the first swab