A Multi-center Single Arm Prospective Study in Patients of Hematological Malignancies Colonized With Carbapenem-resistant Bacterials to Evaluate the Timing of Empirical Antibiotic Treatment (CROEAT Study)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- Incidence of overall mortality
研究概览
简要总结
In this study, we will evaluate the feasibility and clinical outcomes of risk adaptive empirical therapy to cover carbapenem resistance gram negative bacteria (CRO) in patients with hematological malignancies colonized with CRO. Patients assessed by the clinician as being at high risk for CRO infection and requiring intravenous antibiotics covering CRO must meet the following conditions:
- Positive active screening for CRO or past CRO infection or local prevalence of CRO (e.g.,CRO detection rate>20% among recently hospitalized patients);
- Presence of fever or other possible signs and symptoms of infection;
- Neutropenia(ANC<0.1×10^9/L)expected to last for ≥7 days,and having any of the following:
-
Gastrointestinal mucositis/peri-anal infection/intestinal obstruction;
-
Shock or severe sepsis;
-
Respiratory failure:deoxygenated PaO2<60 mmHg or requiring mechanical ventilation;
-
Disseminated intravascular coagulation;
-
Altered mental status or psychiatric abnormalities;
-
Congestive heart failure requiring treatment;
-
Arrhythmia requiring treatment;
-
Recurrence of fever shortly after cessation of or during empirical treatment with carbapenems (≤7 days).
The endpoints of study include incidence of blood-stream infection by CRO, incidence of all causes mortality, incidences of clinical and microbiology response.
详细描述
Neutropenic fever is common in patients with hematological malignancies undergoing chemotherapy or transplantation. Empirical antibiotics therapy is essential treatment principle. In China, recent evidence demonstrated that the carbapenem resistant gram negative bacteria was emerging as an important issue and CRO colonization was positive in about 10% of patients by rectal swab. In such group of patients, the empirical treatment of patients with neutropenic fever therapy remained as a challenge. In this study, we plan to evaluate the feasibility and clinical outcomes of risk adaptive empirical therapy to cover CRO in patients with hematological malignancies colonized with CRO.
Patients assessed by the clinician as being at high risk for CRO infection and requiring intravenous antibiotics covering CRO must meet the following conditions:
- Positive active screening for CRO or past CRO infection or local prevalence of CRO (e.g.,CRO detection rate>20% among recently hospitalized patients);
- Presence of fever or other possible signs and symptoms of infection;
- Neutropenia(ANC<0.1×10^9/L)expected to last for ≥7 days,and having any of the following:
-
Gastrointestinal mucositis/peri-anal infection/intestinal obstruction;
-
Shock or severe sepsis;
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with hematological malignancies receiving hospital treatment such as chemotherapy/immunotherapy/hematopoietic stem cell transplantation;
- •Those with a recent history of CRO colonization or who have been screened for CRO once a week continuously since admission;
- •Patients assessed by the clinician as being at high risk for CRO infection and requiring intravenous antibiotics covering CRO must meet the following conditions:
- •Positive active screening for CRO or past CRO infection or local prevalence of CRO (e.g.,CRO detection rate>20% among recently hospitalized patients);
- •Presence of fever or other possible signs and symptoms of infection;
- •Neutropenia(ANC<0.1×10^9/L)expected to last for ≥7 days,and having any of the following:
- •Gastrointestinal mucositis/peri-anal infection/intestinal obstruction;
- •Shock or severe sepsis;
- •Respiratory failure:deoxygenated PaO2<60 mmHg or requiring mechanical ventilation;
- •Disseminated intravascular coagulation;
- •Altered mental status or psychiatric abnormalities;
- •Congestive heart failure requiring treatment;
- •Arrhythmia requiring treatment;
- •Recurrence of fever shortly after cessation of or during empirical treatment with carbapenems (≤7 days).
- •The patient or their legal guardian has signed the informed consent form.
排除标准
- •Pregnant or breastfeeding women;
- •Individuals who are expected to die within 14 days of hospitalization or have an expected hospital stay of less than 7 days;
- •Any conditions that the investigator believes may increase the risk to the patient;
- •Severe psychological or psychiatric disorders with poor estimated compliance;
- •The presence of any other conditions that the investigator deems unsuitable for participation in this study.
研究组 & 干预措施
Study: empirical treatment
Empirical treatment to cover carbapenem-resistant enterobacterales
干预措施: Empirical treatment (Other)
结局指标
主要结局
Incidence of overall mortality
时间窗: 14 days
Patients died of any causes
次要结局
- Incidence of documented CRE blood stream infection(30 days)
- Clinical response(14 days)
- microbiology response(14 days)