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Brief Title: Screening for Colonization With Resistant Enterobacterales in Neutropenic Patients With Hematologic Malignancies
Official Title: Screening for Colonization With Resistant Enterobacterales in Neutropenic Patients With Hematologic Malignancies (SCENE)
Study ID: NCT04710212
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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
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
Name: Michael Satlin
Affiliation: Weill Medical College of Cornell University
Role: PRINCIPAL_INVESTIGATOR
Name: Vance G Fowler, MD
Affiliation: Duke Clinical Research Institute
Role: STUDY_DIRECTOR