Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Bloodstream Infection
  • Hematologic Malignancy
  • Leukemia, Acute
  • Neutropenia
Type
Observational
Design
Observational Model: CohortTime Perspective: Prospective

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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...

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.

Tracking Information

NCT #
NCT04710212
Collaborators
  • Weill Medical College of Cornell University
  • National Institute of Allergy and Infectious Diseases (NIAID)
Investigators
Principal Investigator: Michael Satlin Weill Medical College of Cornell University Study Director: Vance G Fowler, MD Duke Clinical Research Institute