NCT05311254招募中3 期
A Multicenter Randomized Trial of Fosfomycin vs Ciprofloxacin for Febrile Neutropenia in Hematological Patients: Efficacy and Microbiological Safety
Fundación para la Investigación Biosanitaria del Principado de Asturias1 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2022年3月14日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Febrile neutropenia of infectious origin
研究概览
简要总结
Randomized phase 3 trial to compare efficacy and safety of oral fosfomycin versus ciprofloxacin to prevent febrile neutropenia in patients with acute leukemia or recipients of hematopoietic stem cell transplant.
详细描述
Multicenter, prospective, randomized, open label phase III trial to assess the efficacy and safety of oral fosfomycin vs. oral ciprofloxacin in the prevention of febrile neutropenia in patients with acute leukemia who are treated with intensive chemotherapy and/or are recipients of a hematopoietic stem cell transplant.
Non-inferiority design.
156 patients will be recruited: 78 in each arm
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Subjects who are able to understand study procedures, comply with them, and provide written informed consent before any study-specific procedure.
- •Adult subjects ≥ 18 years of age with acute leukemia diagnosis who are going to receive their first intensive chemotherapy cycle or adult subjects ≥ 18 years of age who are candidates to receive a first stem cell transplant.
- •Expected neutropenia 100x109/L lasting at least seven days. In case of expected neutropenia range 100-500x109/L lasting seven days or more, at least one of the following risk factors for infection must be present:
- •Performance status (Eastern Cooperative Oncology Group, ECOG) ≥
- •Expected mucositis grade 3-
- •Age ≥65 years.
- •Comorbidity Index (HCTI) ≥
- •Serum albumin< 35 g/L.
- •Total dose of etoposide > 500 mg/m2
- •Total dose of cytarabine > 1 g/m2
- •Active or refractory neoplasia at the moment of stem cell transplant.
- •Performance status (Eastern Cooperative Oncology Group, ECOG) of 0 to
- •Adequate organ function defined as:
- •Liver: bilirubin, alkaline phosphatase, or SGOT < 3 times the upper normal limit (unless it is attributable to tumor activity).
- •Renal : creatinine ≤ 250 μmol/l (2.5 mg/dL) (unless it is attributable to AML activity).
- •Life expectancy higher than 3 months.
- •Women of child-bearing potential must not be pregnant or breastfeeding and must have a negative pregnancy test at screening. Women of child-bearing potential and men with female partners of child-bearing potential must agree to practice 2 highly effective contraceptive measures of birth control and must agree not to become pregnant or father a child while receiving any study therapy and for at least 3 months after completing treatment.
排除标准
- •Hypersensitivity to fluoroquinolones or fosfomycin.
- •Treatment with broad spectrum antimicrobial therapy within 4 weeks of first study treatment.
- •Prior Intensive chemotherapy or stem cell transplant. Treatment with hydroxyurea or corticosteroids used to control white blood cell counts are permitted.
- •Fever of infectious origin or documented infection within 4 weeks of first study treatment.
- •Presence of any severe psychiatric disease or physical condition that, according to the physicians criteria, contraindicates the inclusion of the patient into the clinical trial.
- •Subjects that have participated previously in this study
研究组 & 干预措施
Fosfomycin
Experimental
Drug: Fosfomycin: oral capsules containing 700 mg of calcium fosfomycin, equivalent to 500 mg of active drug.
干预措施: Fosfomycin Calcium (Drug)
Ciprofloxacin
Active Comparator
Oral ciprofloxacin, tablets containing 500 mg of active drug.
干预措施: Fosfomycin Calcium (Drug)
结局指标
主要结局
Febrile neutropenia of infectious origin
时间窗: Immediately after the intervention until febrile neutropenia develops, neutrophil count >0,5x109/L up to 60 days maximum
Febrile neutropenia that requires antibacterial treatment.
次要结局
- Use of broad spectrum antibiotics(Immediately after the intervention until febrile neutropenia develops, neutrophil count >0,5x109/L up to 60 days maximum)
- Overall survival(Time from the day of randomization to the date of death, whatever the cause of death, up to 12 weeks.)
- Microbiome evolution(Immediately after the intervention until febrile neutropenia develops, neutrophil count >0,5x109/L up to 60 days maximum)
- Microbiological safety(Immediately after the intervention until febrile neutropenia develops, neutrophil count >0,5x109/L up to 60 days maximum)
- Documented infections(Immediately after the intervention until febrile neutropenia develops, neutrophil count >0,5x109/L up to 60 days maximum)
- Drug related adverse events(Immediately after the intervention until febrile neutropenia develops, neutrophil count >0,5x109/L up to 60 days maximum)
- Evolution of resistome(Immediately after the intervention until febrile neutropenia develops, neutrophil count >0,5x109/L up to 60 days maximum)
研究者
Teresa Bernal del Castillo
Principal investigator
Fundación para la Investigación Biosanitaria del Principado de Asturias
研究点 (1)
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