A prospective, observational, and multi-centric study to evaluate the performance and clinical utility of GeNei Sepsis Kit composed of Bacterial and Fungal Pathogen Detection panels and Antimicrobial Resistance Detection Kit, in comparison to conventional Blood Culture method in patients suspected of sepsis.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 333
- 试验地点
- 5
- 主要终点
- To evaluate the sensitivity of GeNei Sepsis Kit for bacterial and fungal identification and detection of AMR genes in the whole blood of patients suspected of sepsis in comparison to conventional Blood Culture method.
研究概览
简要总结
This study is a prospective, observational, and multicentric study in selected patients, based on the inclusion and exclusion criteria. Subjects are considered enrolled in the study upon signing the Ethics Committee approved Informed Consent Form. A total of 333 subjects will be enrolled in the study, from 3+ sites. This study is designed to evaluate the Performance and Clinical utility of GeNeiTM Sepsis Kit for identification bacterial and fungal pathogens and detection of AMR genes in comparison to conventional Blood Culture method in patients suspected of sepsis. Sepsis is a serious condition that can make people very sick and even lead to death. It happens when the body’s response to an infection causes harm to its own tissues and organs. One of the most important things in treating sepsis is quickly figuring out what germ is causing it so doctors can give the right medicine. Blood culture (BC) is the current `gold standard’ for diagnosing bloodstream pathogens but requires approximately 72 hr to 8 days or more in the case of fastidious bacterial or invasive fungal infection. Sensitivity decreases greatly when antibiotics have been given prior to culture. This delays the start of appropriate antimicrobial therapy and consequently results in worse outcomes and higher mortality rates. GeNeiTM Sepsis Kit, which yields a significantly higher pathogen (bacterial and fungal) detection with high sensitivity and accuracy. The time to identification can be significantly shortened. The Sepsis kit (Bacterial Pathogen Identification kit) is intended to detect the presence of diverse range of pathogenic Gram-Positive and Gram- Negative bacteria and also detects fungi.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient must be 18 years or older.
- •Patients with known or suspected blood stream infection based on clinical observations at the time of screening.
- •Patients exhibiting two or more signs of the systemic inflammatory response syndrome (SIRS): SIRS score equal to or more than 2 (SIRS will be diagnosed when two or more of the following criteria will be present: body temperature, more than 38° C (100.4° F) or less than 36° C (96.8° F); heart rate, more than 90 beats per minute; respiratory rate, equal to or more than 22 breaths per minute; white blood cell count, more than 12,000 cells per µl or less than 4,000 cells per µl or altered mental status).
- •Patient should be able to give informed consent if conscious or if patient is unconscious informed consent to be given by family member or LAR.
排除标准
- •Patient less than 18 years of age.
- •Moribund patient expected to die within 24 hours.
- •After Cardiopulmonary resuscitation.
- •Subjects requiring less than 24hours admission to the ICU (e.g. post operative patients kept for observation) and those patients who are discharged alive from the ICU without developing sepsis are excluded from the study.
- •Subjects who are mentally unsound and those unwilling to participate in the study will be excluded from the study.
- •Subjects with any other clinically significant unstable medical condition, life-threatening disease, or anything else in the opinion of the Investigator that would interfere with the study results.
- •Uncontrolled hypertension, diabetes mellitus or any other co-morbidity that is considered as an exclusion by the Investigator.
结局指标
主要结局
To evaluate the sensitivity of GeNei Sepsis Kit for bacterial and fungal identification and detection of AMR genes in the whole blood of patients suspected of sepsis in comparison to conventional Blood Culture method.
时间窗: 4 WEEKS
次要结局
- To determine(• Positive Predictive Value (PPV) & Negative Predictive Value (NPV))
研究者
Dr Ashwini Kumar
CliniExperts Research Services Pvt Ltd