Evaluation of the CycloPE® Device Used in Patients With a Suspected Bloodstream Infection
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Serious Adverse Events (SAEs) related to the investigational device
研究概览
简要总结
This is a single-center, prospective, single-arm clinical study to evaluate the feasibility, safety, and performance of the PATH EX CycloPE® device on suspected bacteremia-associated sepsis. All participants are adults diagnosed with suspected bacteremia-associated sepsis, admitted to the intensive care unit (ICU), and meet the inclusion criteria.
详细描述
This is a single-center, prospective, single-arm clinical study designed to evaluate the feasibility, safety, and performance of the PATH EX CycloPE® device for the treatment of suspected bacteremia-associated sepsis in critically ill patients. Participants in the study will be adults diagnosed with suspected bacteremia-associated sepsis, admitted to the intensive care unit (ICU), and meeting all inclusion and exclusion criteria. Each patient will undergo two treatments with the PATH EX CycloPE® device. The second treatment will occur 24-36 hours after the start of the first treatment, with each session lasting 4 hours. Clinical and laboratory assessments will be conducted at baseline and predefined intervals during and after the treatment period to monitor safety and evaluate the device's performance.
The primary endpoints focus on feasibility and safety, including device-related adverse events and procedural success. Secondary endpoints will assess infection resolution through microbial eradication, reductions in biomarkers, and changes in hematology and chemistry indices.
The PATH EX CycloPE® device is a novel extracorporeal blood filtration system designed to directly target and remove bacteria from the bloodstream. By addressing the root cause of sepsis, the device has the potential to improve outcomes for critically ill patients.
This study will generate critical data to inform the design of future clinical trials and support the development of this breakthrough technology for the treatment of sepsis. All data will be collected, analyzed, and reported in compliance with Good Clinical Practice (GCP) guidelines and applicable regulatory requirements
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Hospitalized adults (age >= 18 years, male and female)
- •Receiving IV antibiotic therapy
- •Presence of at least 2 of the 4 SIRS criteria:
- •Body temperature > 101°F (38.3°C) or < 96.8°F (36°C);
- •Heart rate > 90 beats per minute;
- •Respiratory rate > 20 breaths per minute;
- •White blood cell count > 12,000/mm³, < 4,000/mm³, or > 10% bands
- •Clinical evidence of new organ dysfunction
- •Procalcitonin (PCT) levels ≥ 0.5 ng/mL
排除标准
- •Inability to maintain a minimum mean arterial pressure of ≥ 65 mmHg despite vasopressor therapy and fluid resuscitation
- •Medical conditions requiring regular blood transfusion
- •Active bleeding (e.g., active GI bleeding, hematuria or epistaxis, untreated coagulopathy or bleeding from a non-compressible site)
- •Absolute neutrophil count less than 500 cells/mm3
- •Platelet count less than 50,000 cells/mm3
- •Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period
- •Known hypersensitivity to Polymyxin E
- •Known hypersensitivity to Vancomycin
- •Subject has known sensitivity/allergy to heparin or has a history of heparin induced thrombocytopenia (HIT)
- •IV antibiotic treatment initiated > 48 hours before baseline screening
- •This exclusion criterion is not applicable for two cases:
- •IV antibiotic treatment initiated > 48 hours before baseline screening has been deemed ineffective based on the clinical judgment of the investigator.
- •If the patient has discontinued IV antibiotic therapy for a continuous period of 24 hours or more within the 48-hour window immediately preceding baseline screening.
- •Participated in an interventional clinical study within 28 days prior to Day 0 or undergoing treatment anticipated to require significant blood draws
- •Have been previously enrolled in this clinical trial
- •History of or known hypercoagulable state
- •Known history of a condition that may result in an increased risk for thrombosis
- •Any other condition, that in the opinion of the investigator, would preclude the subject from being a suitable candidate for enrollment
- •Unable to obtain informed consent from either patient or legally authorized representative
- •Patients who cannot tolerate placement of double-lumen catheter
- •Suspected or confirmed SARS-CoV-2 infection (COVID-19) that cannot be resolved before administration of investigational device.
结局指标
主要结局
Serious Adverse Events (SAEs) related to the investigational device
时间窗: 7 days
The incidence and nature of serious adverse events (SAEs) that are related to the use of the PATH EX CycloPE® device will be assessed to evaluate the safety of the investigational device.
次要结局
- Serious Adverse Events (SAEs) not related to the investigational device or procedure(7 days)
- Clinically significant changes in hematology indices(7 days)
- Clinically significant changes in chemistry indices(7 days)
- Device deficiencies and malfunctions(7 days)
- Clinical and laboratory adverse events (AEs)(7 days)
- Pathogen reduction in the bloodstream(7 days)