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

Duke University

Status: Completed

Conditions: Hematologic Malignancy; Neutropenia; Bloodstream Infection; Leukemia, Acute

Treatments: Other: No intervention.

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT04710212

UM1AI104681 (U.S. NIH Grant/Contract)

Pro00106363

Details and patient eligibility

About

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.

Full 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.

Enrollment: 168 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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

Trial design

168 participants in 2 patient groups

Induction Chemotherapy for Acute Leukemia

Description:

Receiving induction chemotherapy for acute leukemia, and receiving fluoroquinolone (FQ) prophylaxis.

Treatment:

Other: No intervention.

Hematopoietic stem cell transplantation (HCT)

Description:

Undergoing hematopoietic stem cell transplantation (HCT), and receiving fluoroquinolone (FQ) prophylaxis.

Treatment:

Other: No intervention.