Effect of Periodontitis on the Risk of Bloodstream Infection During Intensive Chemotherapy in Patients With Acute Myeloid Leukemia
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Number of participants with Blood stream infections
研究概览
简要总结
This is a prospective, observational study to establish the connection between periodontitis and BSI in AML patients planning to receive intensive chemotherapy.
详细描述
Once eligibility is confirmed, participants will undergo a specialized baseline periodontal examination, gingival sulcus microbiota sampling and saliva sample at baseline before starting chemotherapy.
Patients will be separated into 2 cohorts, with periodontitis (Arm A) and without periodontitis (Arm B). All patients will receive standard oncologic supportive care including antibiotic prophylaxis. Serum samples will be obtained at baseline, at the onset of neutropenic fever, and weekly until day 28 or discharge (whichever sooner).
Study participation will continue during the duration of standard of care chemotherapy for 28 days or until discharge from hospital, whichever later.
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
- •Age >18 years
- •Diagnosis of AML, new diagnosis or relapsed/refractory disease
- •Planned intensive inpatient chemotherapy, defined as expected hospitalization for 4 weeks or longer
- •Sufficient time to perform periodontal examination and treatment by the end of day 1 of chemotherapy without delaying chemotherapy
- •Written informed consent prior to performance of any research related activities
排除标准
- •Unstable for transfer to the School of Dentistry
- •Fever at the time of enrollment
- •Documented blood stream infection at the time of enrollment
- •Inherited bleeding diathesis
- •Periodontitis requiring treatment before starting chemotherapy
- •ANC <0.5 x 10^9/L at the time of enrollment
- •Unstable for transfer to the School of Dentistry
- •Fever at the time of enrollment
- •Documented blood stream infection at the time of enrollment
- •Inherited bleeding diathesis
- •Periodontitis requiring treatment before starting chemotherapy
结局指标
主要结局
Number of participants with Blood stream infections
时间窗: Day 28 of chemotherapy
Number of participants experiencing Blood stream infections (BSI) by day 28 of chemotherapy
次要结局
- Number of participants with Neutropenic fever(Day 28 of chemotherapy)
- Length of hospitalization(Day 28 of chemotherapy)
- Number of participants who died(Day 28 of chemotherapy)
- Number of participants exposed to different antibiotics(Day 28 of chemotherapy)