CompletedNot Applicable

Screening for Colonization With Resistant Enterobacterales in Neutropenic Patients With Hematologic Malignancies

United States168 participantsStarted 2021-03-12

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Ability to provide informed consent
✓. Male or female ≥18 years of age
✓. Receiving intensive induction chemotherapy for acute leukemia or undergoing HCT
✓. Receive fluoroquinolone prophylaxis during neutropenia

Exclusion criteria

✕. Expected to have \<7 days of neutropenia (absolute neutrophil count ≤500 cells/μL) after receipt of chemotherapy (a) (acute leukemia cohort only)
✕. First swab collected ≥5 days after onset of chemotherapy
✕. First swab collected after the day of transplant (HCT cohort only)
✕. Acute promyelocytic leukemia
✕. Receiving chimeric antigen receptor (CAR)-T-cell therapy
✕. Pregnant women as determined by clinician

What they're measuring

Gram-negative bloodstream infection (BSI)

Timeframe: Until neutrophil recovery or 30 days after collection of the first swab in patients who do not have neutrophil recovery by 30 days

Trial details

NCT IDNCT04710212

SponsorDuke University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-12-30

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