Screening for Colonization With Resistant Enterobacterales in Neutropenic Patients With Hematologic Malignancies (SCENE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 168
- 试验地点
- 6
- 主要终点
- Gram-negative bloodstream infection (BSI)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Gram-negative bloodstream infection (BSI)
时间窗: Until neutrophil recovery or 30 days after collection of the first swab in patients who do not have neutrophil recovery by 30 days
Gram-negative BSI during the episode of neutropenia
次要结局
- Colonization with FQRE and ESBL-E(Within 4 days after initiation of chemotherapy)
- 90-day mortality(Occurs within 90 days from the collection of the first swab)
- Bloodstream infection (BSI)(Until neutrophil recovery or 30 days after collection of the first swab in patients who do not have neutrophil recovery by 30 days)
- Fever(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(Prior to neutrophil recovery or 30 days after collection of the first swab in patients who do not have neutrophil recovery by 30 days)