Screening for Colonization With Resistant Enterobacterales in Neutropenic Patients With Hematologic Malignancies
NCT ID: NCT04710212
Last Updated: 2022-04-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
168 participants
OBSERVATIONAL
2021-03-12
2022-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Induction Chemotherapy for Acute Leukemia
Receiving induction chemotherapy for acute leukemia, and receiving fluoroquinolone (FQ) prophylaxis.
No intervention.
Observational study with no intervention.
Hematopoietic stem cell transplantation (HCT)
Undergoing hematopoietic stem cell transplantation (HCT), and receiving fluoroquinolone (FQ) prophylaxis.
No intervention.
Observational study with no intervention.
Interventions
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No intervention.
Observational study with no intervention.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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Weill Medical College of Cornell University
OTHER
National Institute of Allergy and Infectious Diseases (NIAID)
NIH
Duke University
OTHER
Responsible Party
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Principal Investigators
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Michael Satlin
Role: PRINCIPAL_INVESTIGATOR
Weill Medical College of Cornell University
Vance G Fowler, MD
Role: STUDY_DIRECTOR
Duke Clinical Research Institute
Locations
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University of California San Fransisco Medical Center
San Francisco, California, United States
Hackensack Meridian Health
Nutley, New Jersey, United States
Mount Sinai Hospital
New York, New York, 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
Countries
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Other Identifiers
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Pro00106363
Identifier Type: -
Identifier Source: org_study_id
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