EUCTR2013-001997-18-DE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
- 358
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
- •Positive blood (for BSI) or lower respiratory tract (for HABP/VABP)
- •culture that was collected =96 hours prior to randomization meeting any of the following criteria;
- •a. Direct susceptibility testing or susceptibility testing on a purified
- •isolate suggesting a CRE (type 2 carbapenem [any one of: meropenem, imipenem or doripenem] MIC = 4 µg/mL or a disc diffusion zone = 19 mm)
- •b. Isolation of a carbapenemase-producing member of the
- •Enterobacteriaceae
- •c. Identification of a K. pneumoniae isolate from a qualifying culture in a patient from an intensive care unit or ward where =50% of clinical K. pneumoniae isolates are resistant to a type 2 carbapenem
- •d. Identification of an Enterobacteriaceae from a qualifying culture in a patient known to be colonized (urinary, respiratory or gastrointestinal tract) or infected by a CRE in the past 6 months
- •Diagnosis of BSI, HABP, or VABP; all components defining the infection at baseline must have been present within 96 hours prior to randomization
- •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
- •Receipt of more than 72 hours of potentially effective antibacterial
- •therapy prior to randomization
- •– Antibiotic therapy with a narrow spectrum of activity against Grampositive or anaerobic organisms is not restricted (eg, daptomycin, linezolid, metronidazole, nafcillin [or equivalent], cloxacillin, clindamycin, telavancin, teicoplanin, vancomycin, dalbavancin, oritavancin and tedizolid).
- •– Potentially effective antibacterial therapy is defined as the use of any antibiotic for which in vitro susceptibility testing against the index CRE isolate indicates full or intermediate susceptibility according to CLSI breakpoints (M100-S25, Performance
- •Standards for Anti-microbial Susceptibility Testing, January 2015).
- •Where CLSI breakpoints are not available, EUCAST breakpoints may be used (Clinical Breakpoints version 5.0, January 2015).
- •– If the study-qualifying infection occurred while the patient was
- •receiving antibiotics as prophylaxis or for treatment of an unrelated
- •infection, the antibacterial therapy will be considered ineffective
- •irrespective of the susceptibility profile of the study qualifying pathogen.
- •Polymicrobial infections involving two or more aerobic Gram-negative pathogens (ie, not colonizers or contaminants) in the study qualifying culture, with the following exceptions:
- •– Up to two Enterobacteriaceae are permitted
- •– Polymicrobial infections involving CRE and Gram-positive or anaerobic Gram negative pathogens are permitted, provided that the infection can be treated using antibiotics permitted in Section 5.3.2.2
- •Knowledge that the index CRE pathogen is resistant to colistin (MIC > 2 µg/mL) prior to randomization (including Enterobacteriaceae genera with intrinsic resistance to colistin, eg Serratia, Proteus and Providencia)
- •Patients with a requirement for prohibited concomitant therapy
- •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
- •Receipt of high level vasopressors, defined as >0.5 µg/kg/min
- •norepinephrine or equivalent for > 36 hours prior to randomization or need for =2 vasopressors to maintain MAP = 65 mm Hg despite initial adequate fluid resuscitation (30 mL/kg crystalloid or 15 mL/kg of colloid within 6 hours of onset of hypotension) OR an initial serum or blood lactate level of =4 mmol/L that fails to decline >10%/h over the first 8 hours of resuscitation (where lactate results are available)
- •Patients in acute renal failure or on intermittent hemodialysis (IHD) at the time of screening
- •HABP/VABP patients only: Known bronchial obstruction or a history of post-obstructive pneumonia, tracheobronchitis in the absence of
- •concurrent pneumonia, primary lung cancer or malignancies metastatic to the lung, known or suspected active tuberculosis, and currently known or suspected fungal or viral pneumonia. Patients with chronic obstructive pulmonary disease (COPD) are eligible.
研究者
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