Clinical and Microbiological Outcomes of Infections Due to Carbapenem-Resistant Gram-Negative Bacteria
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Clinical success
研究概览
简要总结
Carbapenems are a class of antibiotic agents which kill a broad spectrum of bacteria. Infections due to gram-negative bacteria which have acquired resistance to carbapenems are increasing, especially with Klebsiella pneumoniae, Acinetobacter baumannii and Pseudomonas aeruginosa . The optimal treatment of such infections is not known. Antibiotics like polymyxin, tigecycline and rifampin are used alone or in combination with other antibiotics. The outcome of using these new and old drugs is not well studied. This observational study aims to study the clinical and microbiological outcomes of these infections and treatment at our institution.
详细描述
Objectives
- To define the demographic and risk factor profile of patients acquiring CRGNB infection.
- To define the characteristics of CRGNB infection.
- To report the different treatments employed for CRGNB infection.
- To report the microbiological and clinical outcomes of different treatment options
- a. Microbiological outcomes: frequency of microbiological success. Microbiological success will be defined as two successive negative cultures from the same site as from where the CRGNB was originally isolated.
- b. Clinical outcomes: clinical success (clinical cure), adverse effects of treatment especially the nephrotoxicity in relation to the use of polymyxin, ICU length of stay (if applicable), hospital length of stay, ICU mortality (if applicable), hospital mortality and in-hospital recurrence of infection. Clinical success will be defined as resolution or improvement of clinical symptoms and signs of infection and discontinuation of the antibiotics.
Study duration:
We plan to collect the data for a one year period. Based on the current prevalence rate at our institution, we anticipate having data for 300 patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Adult in-patients (age≥18 years) having an infection due to CRGNB (Klebsiella pneumoniae, Acinetobacter baumannii and Pseudomonas aeruginosa only). CRGNB Infection will be defined as isolation of CRGNB from any source requiring treatment with anti-infective agents with or without manifestations of systemic inflammatory response syndrome.
排除标准
- •Patients colonized with CRGNB and not having an active infection.
- •Recurrent infection in a previously included patient.
结局指标
主要结局
Clinical success
时间窗: At the end of treatment
Resolution (or improvement) of clinical symptoms and signs of infection and discontinuation of the antibiotics.
次要结局
- Microbiological success(At the end of treatment)
- Recurrence rate(During the hospital stay)
- Adverse effects of treatment(During treatment with antibiotics)
- Hospital length of stay(During the hospital stay)
- Mortality(During hospital stay)