Status:
COMPLETED
Screening for Colonization With Resistant Enterobacterales in Neutropenic Patients With Hematologic Malignancies
Lead Sponsor:
Duke University
Collaborating Sponsors:
Weill Medical College of Cornell University
National Institute of Allergy and Infectious Diseases (NIAID)
Conditions:
Hematologic Malignancy
Leukemia, Acute
Eligibility:
All Genders
18+ years
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...
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...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 12 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 28 2022
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT04710212
Start Date
March 12 2021
End Date
February 28 2022
Last Update
April 6 2022
Active Locations (6)
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1
University of California San Fransisco Medical Center
San Francisco, California, United States, 94143
2
Hackensack Meridian Health
Nutley, New Jersey, United States, 07110
3
Mount Sinai Hospital
New York, New York, United States, 10029
4
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, United States, 25714