EUCTR2018-001476-37-ES进行中（未招募）1 期
Efficacy of extended infusion of ß-lactam antibiotics for the treatment of febrile neutropenia in hematologic patients (BEATLE study).
Dra. Carlota Gudiol González. Servicio de Enfermedades Infecciosas. Hospital Universitari de Bellvitge.0 个研究点目标入组 150 人开始时间: 2019年4月11日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •1)Adult patients (age =18 years) of both sexes
- •2)Patients admitted in Hematological ward
- •3) With any of the following diagnoses:
- •3.1)Acute leukemia undergoing induction or consolidation chemotherapy
- •3.2)Autologous or allogeneic hematopoietic stem cell transplant recipients
- •4) With an episode of Febrile Neutropenia: = 38.0ºC and <500 neutrophils / mm3 or <1000 with a predicted decrease within 24-48 hours
- •5)Patient requires treatment with ABL: cefepime, piperacillin /tazobactam or meropenem, in monotherapy or in combination with another antibiotic.
- •6)The patient or his legal representative grants their consent by signing the informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 110
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 44
排除标准
- •1)Allergy to study drugs
- •2)Patient receiving systemic antibiotic treatment (except for prophylaxis) at the time of onset of febrile neutropenia.
- •3)Absence of fever
- •4)Patients with epilepsy
- •5)Severe renal impairment (defined as creatinine clearance rate MDR / CKD-EPI <30 mL / min)
- •6)Previously enrolled patients in whom the time between the inclusion and the current episode is less than 5 weeks
- •7)Patients who have participated previously in this trial without current resolution of the first episode.
研究者
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