An observational study in Hematologic Malignancy, Leukemia, Acute and Neutropenia, sponsored by Duke University. Completed at 6 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-06.
Sponsored by Duke University · Observational
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. The combined data will be used for study analysis and reporting.
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410 adults with acute leukemia who are receiving induction chemotherapy and HCT recipients who are receiving FQ prophylaxis during neutropenia.
Exclusion Criteria:
Receiving induction chemotherapy for acute leukemia, and receiving fluoroquinolone (FQ) prophylaxis.
Other: No intervention.
Undergoing hematopoietic stem cell transplantation (HCT), and receiving fluoroquinolone (FQ) prophylaxis.
Other: No intervention.
Observational study with no intervention.
Gram-negative bloodstream infection (BSI)
Gram-negative BSI during the episode of neutropenia
Time frame: Until neutrophil recovery or 30 days after collection of the first swab in patients who do not have neutrophil recovery by 30 days
Colonization with FQRE and ESBL-E
Colonization with fluoroquinolone-resistant Enterobacterales (FQRE) and Extended-spectrum-beta-lactamase-producing Enterobacterales (ESBL-E) upon initiation of chemotherapy
Time frame: Within 4 days after initiation of chemotherapy
Fever
Occurrence (Yes/No) of fever (≥38.0°C) during the episode of neutropenia.
Time frame: Until neutrophil recovery or 30 days after collection of the first swab in patients who do not have neutrophil recovery by 30 days
Bloodstream infection (BSI)
Any BSI during the episode of neutropenia
Time frame: Until neutrophil recovery or 30 days after collection of the first swab in patients who do not have neutrophil recovery by 30 days
Intensive care unit (ICU) admission
Intensive care unit admission prior to recovery from neutropenia
Time frame: Prior to neutrophil recovery or 30 days after collection of the first swab in patients who do not have neutrophil recovery by 30 days
90-day mortality
90-day mortality from the collection of the first swab
Time frame: Occurs within 90 days from the collection of the first swab
Incidence of and risk factors for acquiring FQRE and ESBL-E during the episode of neutropenia
Acquisition of FQRE and ESBL-E in patients not initially colonized with these organisms
Time frame: During the episode of neutropenia, up to 30 days
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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