EUCTR2018-000775-32-ES进行中（未招募）1 期
Phase IV, randomized, open, parallel groups clinical trial for evaluating the early Stop of antibiotic Treatment in febrile neutropenic Oncohematological Paediatric patients. - eSTOP-study
Vall d'Hebron Institut de Recerca0 个研究点目标入组 250 人开始时间: 2018年4月9日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 250
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
- 性别
- All
入选标准
- •-Female and male outpatients =18 years with haematological or solid malignancies.
- •-Admission due to FN (defined as an axillary temperature >38.3°C or two consecutive readings of >38.0°C for 1 hour and an absolute neutrophil count <0.5 neutrophils/mm3, or expected to fall below 0.5 neutrophils/mm3 during the next 48 hours).
- •-Antibiotic treatment initiated in the current FN episode (prior standard antimicrobial prophylaxis will be accepted).
- •-Low risk of invasive bacterial infection at admission:
- •oNone of the following: serum level of CRP = 9 mg/dl, hypotension, relapse of leukemia as type of cancer, platelet count =50,000 platelets/mm3, initiation of fever less than 7 days from last chemotherapy). Platelet count =50,000 platelets/mm3 or initiation of fever less than 7 days from the last chemotherapy alone will be accepted.
- •-Absence of a demonstrated bacterial infection at 48h-72 hours after admission (positive culture from a sterile site, clinically diagnosed infection or radiologically confirmed pneumonia).
- •-Good clinical evolution at 48-72 hours after admission (afebrile >24h (temperature =38ºC), haemodinamic stability, stable pediatric assessment triangle).
- •-CRP = 5 mg/dl and PCT = 0.5 ng/dl at 48-72 hours after admission.
- •-ANC < 0.5 neutrophils/mm3 at 48-72 hours after admission.
- •-Patient/parent(s)/legal representative(s) must possess writing and reading abilities sufficient to comprehend the study.
- •-Patient/parent(s)/legal representative(s) is considered reliable and capable of adhering to the protocol.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 250
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Patient that has undergone stem cell transplantation
- •-Patient with acute myeloblastic leukemia or Philadelphia-positive acute lymphoblastic leukemia
- •-Admission due to other cause different from FN.
- •-Antibiotic treatment prior to admission other than the usual antimicrobial prophylaxis.
- •-Empiric antibiotic therapy not in accordance with internal protocol.
- •-Confirmed allergy to betalactams.
- •-Bad clinical evolution in the first 12 hours after admission (haemodinamic instability, admission to PICU, death).
- •-Actively participating in the study at the beginning of the current FN episode.
- •-Concurrent participation in any other clinical trial.
- •-Any condition for which, in opinion of the investigator, participation would not be in the best interest of the patient or that could prevent, limit or confound the protocol-specified assessments.
- •- Female subjects who are pregnant or breast-feeding
- •- Signed informed consent by patient/parent(s)/legal representative(s).
研究者
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