Evaluation of Droplet Digital PCR Rapid Detection Method and Precise Diagnosis and Treatment for Suspected Sepsis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,032
- 试验地点
- 16
- 主要终点
- Sensitivity
研究概览
简要总结
Sepsis is a significant public health concern worldwide, with high morbidity and mortality. With regard to a targeted antimicrobial treatment strategy, the earliest possible pathogen detection is of crucial importance. Until now, culture-based detection methods represent the diagnostic gold standard, although they are characterized by numerous limitations. Culture-independent molecular diagnostic procedures may represent a promising alternative. In particular, droplet digital PCR (ddPCR) is a novel one-step PCR assay that achieves higher accuracy and sensitivity in detecting causing pathogens in patients with bloodstream infections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •1.18 years or older
- •2.Meet 2 of 4 sepsis criteria
- •Temperature > 38C or < 36C
- •Heart rate > 90 bpm
- •Respiratory rate >20 or PaCO2 <32mmHg
- •WBC >12000/µL or < 4000/µL or > 10% bands
- •3.Hospitalized patients who have a diagnostic blood culture ordered as standard of care for suspected sepsis
- •4.Informed Consent by patient or legal representative.
排除标准
- •Refusal to participate in the study or Failure to comply with treatment or follow-up time
- •Known breastfeeding or pregnancy
- •The researcher believes that there are any conditions (social or medical) that allow subjects to participate is unsafe. For example, severe anemia or high risk of bleeding,etc., which are not suitable for taking peripheral blood for testing
- •Participating in other clinical studies
结局指标
主要结局
Sensitivity
时间窗: Up to 96 hours post blood collection
The primary endpoint of estimated sensitivity will be determined by comparing positive blood culture results with the concomitantly collected ddPCR results from the prospective clinical specimens.
Specificity
时间窗: Up to 96 hours post blood collection
The primary endpoint of estimated specificity will be determined by comparing negative blood culture results with the concomitantly collected ddPCR results from the prospective clinical specimens.
次要结局
- Ventilation duration in ICU (hours)(Up to the end of study participation, an average of 1 year)
- Duration of antimicrobials(Up to the end of study participation, an average of 1 year)
- Days in hospital (from study inclusion)(Up to the end of study participation, an average of 1 year)
- Treatment costs(Up to the end of study participation, an average of 1 year)
- Change in condition severity(Up to the end of study participation, an average of 1 year)
- Time to the change to the targeted antimicrobial therapy(At time point of change to the targeted antimicrobial therapy, up to 96 hours post blood collection)
- Number of patients with targeted antimicrobial therapy(Up to the end of study participation, an average of 1 year)
- Time to identification of a potential pathogen(At time point of identification of a potential pathogen, up to 96 hours post blood collection)
- Days in intensive care unit (ICU)(Up to the end of study participation, an average of 1 year)
- All-cause death(Up to the end of study participation, an average of 1 year)
- Quality of life of survivors after being discharged(Up to the end of study participation, an average of 1 year)
研究者
Wen-hong Zhang
Director of Division of Infectious Diseases
Huashan Hospital