EUCTR2013-001997-18-FR进行中（未招募）1 期
A Phase 3, Multicenter, Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Plazomicin Compared with Colistin in Patients with Infection due to Carbapenem-Resistant Enterobacteriaceae (CRE)
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 69
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
- •Male and female patients age 18 to 85 years, inclusive
- •APACHE II score between 15 and 30, inclusive
- •Presumptive identification of a carbapenem resistant-member of the Enterobacteriaceae as defined by rapid testing methods from an appropriate culture specimen = 72 hours prior to study OR definitive identification of a carbapenem resistant-member of the Enterobacteriaceae as defined by local lab identification and susceptibility testing from an appropriate culture specimen = 72 hours prior to study entry
- •Diagnosis of BSI as defined by at least one positive blood culture meeting the above microbiological criteria associated with at least one of the following signs of infection: Fever or hypothermia; New onset arterial hypotension; Elevated total peripheral white blood cell (WBC) count > 10,000 cells/mm3, > 15% immature neutrophils (band forms) regardless of total peripheral WBC count, or leukopenia with total WBC count < 4500 cells/mm3
- •Or, diagnosis of nosocomial pneumonia in a patient on mechanical ventilation, as defined by lower respiratory tract or pleural fluid culture meeting the above defined microbiological criteria, and associated with the following clinical signs of pneumonia: A chest X-ray or computed tomography (CT) scan with findings consistent with a diagnosis of pneumonia; Worsening gas exchange; Purulent deep respiratory specimen; AND one of the following: Elevated total peripheral WBC count > 10,000 cells/mm3, > 15% immature neutrophils (band forms) regardless of total peripheral WBC count, or leukopenia with total WBC count < 4500 cells/mm3; Fever or hypothermia
- •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 179
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 179
排除标准
- •Patient has received more than 72 hours of empirical therapy
- •Infection with CRE isolate with reduced susceptibilty to colistin
- •Presence of refractory septic shock
- •Objective clinical evidence for any of the following clinical syndromes that necessitates antimicrobial therapy for greater than 14 days: endovascular infection including endocarditis, osteomyelitis, prosthetic joint infection, meningitis and/or other central nervous system infections
- •Objective clinical evidence of infectious involvement of intravascular material not intended to be removed within 4 calendar days of initial positive culture
- •Pulmonary disease that precludes evaluation of therapeutic response including known bronchial obstruction or a history of post-obstructive pneumonia, tracheobronchitis, primary lung cancer or malignancies metastatic to the lung, bronchiectasis, known or suspected active tuberculosis
- •Patients with severe liver disease (Child-Pugh score of Class C)
- •Patients in acute renal failure or on intermittent hemodialysis (IHD) at the time of screening
- •Patients with a history of seizure disorder and who are receiving anti-convulsive therapy
- •Diagnosis of myasthenia gravis or any other neuromuscular disorder
研究者
相似试验
进行中（未招募）
1 期
A Phase 3 Study to Compare Avelumab Given Alone or Given in Combination with Pegylated Liposomal Doxorubicin Compared to Pegylated Liposomal Doxorubicin Given Alone Patients with Platinum-Resistant/Refractory Ovarian CancerOvarian CancerMedDRA version: 20.0 Level: PT Classification code 10033128 Term: Ovarian cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2015-003091-77-PLPfizer Inc., 235 East 42nd Street, New York, NY 10017550
进行中（未招募）
1 期
A clinical trial to assess and compare overall survival (OS) between guadecitabine and treatment choice (TC) in adults with previously treated acute myeloid leukemia (AML)Acute Myeloid Leukemia (AML)MedDRA version: 20.0Level: HLTClassification code 10024291Term: Leukaemias acute myeloidSystem Organ Class: 100000004851EUCTR2015-005256-97-BEAstex Pharmaceuticals, Inc.300
进行中（未招募）
1 期
A Phase 3 Study to Compare Avelumab Given Alone or Given in Combination with Pegylated Liposomal Doxorubicin Compared to Pegylated Liposomal Doxorubicin Given Alone Patients with Platinum-Resistant/Refractory Ovarian CancerOvarian CancerEUCTR2015-003091-77-NLPfizer Inc., 235 East 42nd Street, New York, NY 10017550
进行中（未招募）
1 期
A clinical trial to compare guadecitabine (SGI-110) to other available therapies in patients with myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML) who have previously been treated with hypomethylating agentsEUCTR2015-005257-12-DKAstex Pharmaceuticals, Inc.408
已完成
3 期
Phase 3 Randomized, Open-Label Study of Guadecitabine vs Treatment Choice in Previously Treated Acute Myeloid Leukemiaacute myeloid leukemiaJPRN-jRCT2080223674Otsuka Pharmaceutical Co., Ltd.400