Rapid Identification of Microbial Pathogens in Intra-abdominal Infections Using Multiplex PCR
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Time to availability of multiplex PCR result (in days)
研究概览
简要总结
With this study, the investigators want to determine whether a fast identification of microorganisms causing intra-abdominal infections in patients with suspected hollow organ perforation or peritonitis is possible using a multiplex PCR system (Unyvero A50), a method that allows rapid detection of predefined bacterial and fungal targets directly from clinical samples. Therefore, intra-abdominal peritoneal fluid samples collected during surgery will be analyzed by multiplex PCR and by conventional microbiological culture. The investigators want to determine whether multiplex PCR diagnostics could provide results faster than conventional microbiological methods and deliver additional information on pathogen detection.
详细描述
This prospective observational study evaluates a rapid multiplex PCR system (Unyvero A50, Curetis) as an adjunct to conventional microbiological culture (cMB) in adult patients undergoing surgery for suspected hollow viscus perforation or peritonitis. During surgery, two intra-abdominal peritoneal fluid samples will be collected. One sample will be processed by routine aerobic and anaerobic culture at the microbiology laboratory. The second sample will be analyzed postoperatively using multiplex PCR at the surgical intensive care unit according to the manufacturer's instructions.
The study will compare turnaround time and concordance of pathogen detection between multiplex PCR and cMB. Additional descriptive analyses will include pathogen group distributions, polymicrobial findings, and results by anatomical site of perforation. Resistance markers detected by PCR will be recorded descriptively. Invalid PCR results will be documented and excluded from paired analyses.
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
- •suspected hollow organ perforation
- •suspected peritonitis
- •patient underwent surgical treatment
- •microbiological testing of intra-abdominal fluid was needed
排除标准
- •patient in moribund conditions
- •patient already enrolled in an interventional clinical trial
- •patient under 18
结局指标
主要结局
Time to availability of multiplex PCR result (in days)
时间窗: Up to 1 day post-sampling
Time from intraoperative peritoneal fluid sampling to availability of the multiplex PCR result (reported in days)
Time to availability of conventional microbiological culture result (in days)
时间窗: Up to 7 days post-sampling
Time from intraoperative peritoneal fluid sampling to availability of the final conventional microbiological culture report (reported in days)
次要结局
- Concordance of pathogen detection between multiplex PCR and conventional culture(Perioperative (up to 7 days post-sampling))
研究者
Dr. T. Perl
Principal Investigator
University of Göttingen