Clinical trial · Observational
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)
NCT04710212CI-TRIAL-00057605SCENEcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bloodstream Infection | — | UNRESOLVED | — |
| Hematologic Malignancy | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| Leukemia, Acute | Acute Leukemia | ONTOLOGY_EXACT | 0.90 |
| Neutropenia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No intervention. | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Induction Chemotherapy for Acute Leukemia
- description
- Receiving induction chemotherapy for acute leukemia, and receiving fluoroquinolone (FQ) prophylaxis.
- interventionNames
- Other: No intervention.
- label
- Hematopoietic stem cell transplantation (HCT)
- description
- Undergoing hematopoietic stem cell transplantation (HCT), and receiving fluoroquinolone (FQ) prophylaxis.
- interventionNames
- Other: No intervention.
Primary outcomes (1)
- measure
- 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
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.