Trials / Completed
CompletedNCT04710212
Screening for Colonization With Resistant Enterobacterales in Neutropenic Patients With Hematologic Malignancies
Screening for Colonization With Resistant Enterobacterales in Neutropenic Patients With Hematologic Malignancies (SCENE)
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 168 (actual)
- Sponsor
- Duke University · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | No intervention. | Observational study with no intervention. |
Timeline
- Start date
- 2021-03-12
- Primary completion
- 2021-12-30
- Completion
- 2022-02-28
- First posted
- 2021-01-14
- Last updated
- 2022-04-06
Locations
6 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT04710212. Inclusion in this directory is not an endorsement.