Optimizing antimicrobial treatment strategy for Carbapenem resistant Klebsiella pneumoniae bacteremia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- The integrated stewardship approach based on evidence-based recommendation will help to develop a standard treatment guideline for difficult to treat CR-Kp infections.
研究概览
简要总结
This will be a multi-centric prospective interventional study that involves developing and applying treatment strategies for CR-Kp concerning clinical outcomes, carbapenemase genotype, and cost-effectiveness. Treatment strategies will be developed based on analyzing existing treatment patterns, collected retrospectively and correlating the genotypic pattern with clinical outcomes of CR-Kp. Focus group discussion will be conducted to finalize the developed dosing strategies. The effectiveness of the developed treatment strategies will be studied through an interventional design. Cost-effectiveness analysis of the developed strategy over the conventional strategies will be evaluated. Outcomes for safety and efficacy of the developed strategy will be analyzed. Outcomes from this study would enable the developing of clinical practice guidelines for antimicrobial therapy of CR-Kp, which would help in optimizing therapy based on genotypic analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •patients diagnosed with blood stream infections due to carbapenem resistant klebsiella penumoniae anytime during their hospital stay.
排除标准
- •patients received from outside hospital who had a positive culture for bacteremia after 48 hours, patients with polymicrobial bacteremia, patients with cystic fibrosis, patients who do not have a carbapenem susceptibility test or noninterpretable susceptibility test.
结局指标
主要结局
The integrated stewardship approach based on evidence-based recommendation will help to develop a standard treatment guideline for difficult to treat CR-Kp infections.
时间窗: After obtaining culture positive sample for Cr-Kp
次要结局
- Optimization of appropriate antibiotic regimen based on the genotype of CR-Kp will help in individualized antimicrobial therapy, providing better outcomes of the patient & prevent treatment failure or antimicrobial resistance.(After obtaining a positive blood culture for Cr-Kp)
- Cost-effectiveness analysis of incorporating PCR techniques in CR-Kp will help in better management of patients in low-middle socioeconomic countries like India.(Throughout the hospital stay of the patients based on clinical outcomes)
研究者
Vishal Shanbhag
Kasturba Medical College, Manipal Academy of Higher Education, Manipal