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

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ClinicalTrials.gov Identifier: NCT04710212
Recruitment Status : Recruiting
First Posted : January 14, 2021
Last Update Posted : March 23, 2021
Sponsor:
Collaborators:
Weill Medical College of Cornell University
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Hematologic Malignancy Leukemia, Acute Neutropenia Bloodstream Infection 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.

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Study Type : Observational
Estimated Enrollment : 410 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Screening for Colonization With Resistant Enterobacterales in Neutropenic Patients With Hematologic Malignancies (SCENE)
Actual Study Start Date : March 11, 2021
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 initiation of chemotherapy ]
    90-day mortality from the initiation of chemotherapy


Other Outcome Measures:
  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


Biospecimen Retention:   Samples Without DNA
Perianal swabs are collected from subjects and only isolates are retained. Bloodstream infection isolates are retained.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04710212


Contacts
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Contact: Michael Satlin, MD, MS 212-746-7431 mjs9021@med.cornell.edu
Contact: Nyssa Schwager 919-402-3528 nyssa.schwager@duke.edu

Locations
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United States, California
University of California San Fransisco Medical Center Not yet recruiting
San Francisco, California, United States, 94143
Contact: Danaya Shariff    415-476-4862      
Principal Investigator: Sarah Doernberg, MD, MAS         
United States, New Jersey
Hackensack Meridian Health Not yet recruiting
Nutley, New Jersey, United States, 07110
Contact: Mariefel Vendivil    551-996-5828      
Principal Investigator: Scott Rowley, MD         
United States, New York
Mount Sinai Hospital Not yet recruiting
New York, New York, United States, 10029
Contact: Tasha Vazquez    917-860-1449      
Principal Investigator: Samantha Jacobs, MD, MS         
United States, North Carolina
University of North Carolina Chapel Hill Not yet recruiting
Chapel Hill, North Carolina, United States, 25714
Contact: Cheryl Hendrickson    919-843-2541      
Principal Investigator: David van Duin, MD, PhD         
United States, Oregon
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Sarah Siegel    503-494-1384      
Principal Investigator: Morgan Hakki, MD         
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Wendy Liang    412-648-6536      
Principal Investigator: Ryan Shields, PharmD, MS         
Sponsors and Collaborators
Duke University
Weill Medical College of Cornell University
National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
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Principal Investigator: Michael Satlin Weill Medical College of Cornell University
Study Director: Vance G Fowler, MD Duke Clinical Research Institute
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT04710212    
Other Study ID Numbers: Pro00106363
UM1AI104681 ( U.S. NIH Grant/Contract )
First Posted: January 14, 2021    Key Record Dates
Last Update Posted: March 23, 2021
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Duke University:
FQRE
Fluoroquinolone-resistant Enterobacterales
Hematopoietic stem cell transplantation
HCT
Induction chemotherapy
Hematologic Malignancy
Acute Leukemia
Neutropenia
Bloodstream infection
Perianal swab
Gram-negative bacteremia
Additional relevant MeSH terms:
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Sepsis
Neoplasms
Hematologic Neoplasms
Neutropenia
Infection
Neoplasms by Site
Hematologic Diseases
Agranulocytosis
Leukopenia
Leukocyte Disorders
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes