Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
estimated completion
Principal Investigator
by Sarah Doernberg, MD, MAS (ucsf)
Photo of Sarah Doernberg
Sarah Doernberg

Description

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.

Official Title

Screening for Colonization With Resistant Enterobacterales in Neutropenic Patients With Hematologic Malignancies (SCENE)

Details

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.

Keywords

Hematologic Malignancy Leukemia, Acute Neutropenia Bloodstream Infection FQRE Fluoroquinolone-resistant Enterobacterales Hematopoietic stem cell transplantation HCT Induction chemotherapy Acute Leukemia Perianal swab Gram-negative bacteremia Sepsis Neoplasms Hematologic Neoplasms No intervention. Induction Chemotherapy for Acute Leukemia Hematopoietic stem cell transplantation (HCT)

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Ability to provide informed consent
  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

You CAN'T join if...

  1. Expected to have <7 days of neutropenia (absolute neutrophil count ≤500 cells/μL) after receipt of chemotherapy (a) (acute leukemia cohort only)
  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

Locations

  • University of California San Fransisco Medical Center accepting new patients
    San Francisco California 94143 United States
  • Oregon Health and Science University accepting new patients
    Portland Oregon 97239 United States

Lead Scientist at UC Cancer

  • Sarah Doernberg, MD, MAS (ucsf)
    Sarah Doernberg is an Associate Professor in the Division of Infectious Diseases and the Medical Director of Adult Antimicrobial Stewardship at UCSF Medical Center. She has an active outpatient Infectious Diseases Clinic and sees inpatients on the Transplant Infectious Diseases service. Her clinical research focuses on healthcare-acquired infections and antimicrobial stewardship.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Duke University
ID
NCT04710212
Study Type
Observational
Last Updated