In Vitro Activity of Ceftolozane/Tazobactam and Imipenem/Relebactam in Clinical Isolates of Pseudomonas Aeruginosa and Enterobacterales Collected From Hematology and Oncology Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,005
- 试验地点
- 1
- 主要终点
- Summary of percentages of isolates
研究概览
简要总结
The purpose of the ACTHEON Study is to evaluate the in vitro activity of ceftolozane-tazobactam, imipenem-relebactam and comparator agents (amoxicillin- clavulanate, piperacillin-tazobactam, ceftazidime, cefotaxime, cefepime, imipenem, meropenem, levofloxacin and amikacin; see list more details on page 7) against clinical isolates of P. aeruginosa and Enterobacterales prospectively collected from hematology and oncology patients with complicated intra-abdominal infections (cIAIs), complicated urinary infections (cUTIs), lower respiratory tract infections (LRTIs), and blood stream infections (BSIs) from 15 participating centers in Spain
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •P. aeruginosa isolates
- •Enterobacterales isolates
排除标准
- •Non P. aeruginosa isolates
- •Non Enterobacterales isolates
研究组 & 干预措施
P. aeruginosa isolates
All isolates will be sent to the Central Laboratory, where identification will be confirmed by MALDI-TOF and susceptibility testing against ceftolozane/tazobactam, imipenem- relebactam and comparative agents will be performed
干预措施: Ceftolozane/tazobactam (Drug)
P. aeruginosa isolates
All isolates will be sent to the Central Laboratory, where identification will be confirmed by MALDI-TOF and susceptibility testing against ceftolozane/tazobactam, imipenem- relebactam and comparative agents will be performed
干预措施: imipenem- relebactam (Drug)
Enterobacterales isolates
All isolates will be sent to the Central Laboratory, where identification will be confirmed by MALDI-TOF and susceptibility testing against ceftolozane/tazobactam, imipenem- relebactam and comparative agents will be performed
干预措施: Ceftolozane/tazobactam (Drug)
Enterobacterales isolates
All isolates will be sent to the Central Laboratory, where identification will be confirmed by MALDI-TOF and susceptibility testing against ceftolozane/tazobactam, imipenem- relebactam and comparative agents will be performed
干预措施: imipenem- relebactam (Drug)
结局指标
主要结局
Summary of percentages of isolates
时间窗: 31 october 2020
Summary of percentages of isolates interpreted as susceptible, intermediate and resistant isolates according to CLSI and EUCAST guidelines, when available, for each species and for the total study isolates.
Summary MIC and its distributions as susceptible, intermediate and resistant
时间窗: 31 october 2020
Summary of MIC data, distribution presented as the cumulative MIC frequency, MIC50, MIC90, and MIC range for each antimicrobial and species.
次要结局
未报告次要终点
研究者
Emilio Bouza
Phd, MD Senior Assesor
Hospital General Universitario Gregorio Marañon