Early Diagnosis and Treatment of Periodontal Disease in Patients With AML to Reduce Bloodstream Infections During Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Incidence of neutropenic fever (NF) by day 28 of chemotherapy or discharge
研究概览
简要总结
This is a phase 2 randomized controlled trial of pre-chemotherapy periodontal deep cleaning in Acute Myelogenous Leukemia (AML) patients with asymptomatic periodontitis.
Once eligibility is confirmed, participants with periodontitis will be randomized in a 1:1 ratio to undergo treatment by scaling and root planing (SRP, "deep cleaning") (arm A) or receive no periodontal treatment (arm B). We will compare the incidence of Blood Stream Infection (BSI) during chemotherapy between the two arms.
Study participation will continue until day 28 of chemotherapy or discharge from hospital, whichever occurs first.
详细描述
Bloodstream infection (BSI) is common in patients with acute myeloid leukemia (AML) and causes significant morbidity and mortality. Chemotherapy disrupts oral and intestinal mucosal barriers, facilitating bacterial translocation to the bloodstream.
Baseline periodontitis is associated with higher risk of BSI during chemotherapy. In AML patients, since baseline screening and treatment of asymptomatic periodontitis is currently not a standard practice, the researchers are hoping to (i) personalize supportive care according to patient-specific risk factors; (ii) promote an interdisciplinary approach to supportive care by bringing periodontists into the treatment team; (iii) improve quality of life by reducing hospitalization length; (iv) decrease the incidence of re-hospitalization during future phases of treatment; (v) decrease early treatment related mortality (TRM); and (vi) decrease healthcare costs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
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
- •Newly diagnosed or relapsed AML
- •Planned intensive chemotherapy (Any regimen expected to require 3-4 weeks of inpatient stay)
- •Antibacterial prophylaxis using levofloxacin 500 mg daily
- •Sufficient time to perform periodontal examination and treatment by day 1 of chemotherapy
排除标准
- •Prior treatment for AML, except hydroxyurea or leukapheresis
- •ANC <0.5 x 10^9/L at the time of enrollment
- •Post-transfusion platelet count <50x10^9/L at the time of enrollment
- •Unstable for transfer to the School of Dentistry
- •Fever at the time of enrollment
- •Documented infection at the time of enrollment
- •SRP in the last 3 months
- •Symptomatic periodontal disease
结局指标
主要结局
Incidence of neutropenic fever (NF) by day 28 of chemotherapy or discharge
时间窗: Day 28 or discharge date (whichever occurs first)
次要结局
- Incidence of BSI by day 28 of chemotherapy or discharge(Day 28 or discharge date (whichever occurs first))
- Incidence of blood culture-negative NF by day 28 of chemotherapy or discharge, whichever occurs first(Day 28 or discharge date (whichever occurs first))
- Incidence of oral mucositis by day 28 of chemotherapy or discharge, whichever occurs first(Day 28 or discharge date (whichever occurs first))
- Incidence of death by day 28(Day 28 or discharge date (whichever occurs first))
- Number of days hospitalized(Upto 8 weeks)
- Incidence of Neutropenic Fever within 2 days after periodontal examination/treatment (safety endpoint)(within 2 days after periodontal examination/treatment)