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Spots Global Cancer Trial Database for Screening for Colonization With Resistant Enterobacterales in Neutropenic Patients With Hematologic Malignancies

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We do not endorse or review these studies in any way.

Trial Identification

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

Interventions

No intervention.

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

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

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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