An interventional study of PATH EX CycloPE® Device in Sepsis, Infection and Bacteremia Sepsis, sponsored by PATH EX, Inc.. Active, not recruiting at 1 site in Armenia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-14.
Sponsored by PATH EX, Inc. · Not applicable, Interventional, and Treatment
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.
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
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 15 is below the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →This is the only study on the registry with PATH EX, Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: 1. Hospitalized adults (age >= 18 years, male and female) 2. Receiving IV antibiotic therapy 3. Presence of at least 2 of the 4 SIRS criteria:
Exclusion Criteria: 1. Inability to maintain a minimum mean arterial pressure of ≥ 65 mmHg despite vasopressor therapy and fluid resuscitation 2. Medical conditions requiring regular blood transfusion 3. Active bleeding (e.g., active GI bleeding, hematuria or epistaxis, untreated coagulopathy or bleeding from a non-compressible site) 4. Absolute neutrophil count less than 500 cells/mm3 5. Platelet count less than 50,000 cells/mm3 6. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period 7. Known hypersensitivity to Polymyxin E 8. Known hypersensitivity to Vancomycin 9. Subject has known sensitivity/allergy to heparin or has a history of heparin induced thrombocytopenia (HIT) 10. IV antibiotic treatment initiated > 48 hours before baseline screening
This exclusion criterion is not applicable for two cases:
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.
Treated with PATH EX CycloPE® Device
Device: PATH EX CycloPE® Device
Participants in this arm will receive two extracorporeal blood filtration treatments using the PATH EX CycloPE® device. The first treatment will be initiated following baseline assessments, and the second treatment will occur 24-36 hours after the start of the first treatment. Each treatment will last up to 4 hours. The device is designed to target and remove bacteria from the bloodstream. All participants will also receive standard-of-care treatment for sepsis, including IV antibiotics, as determined by the treating physician.
Serious Adverse Events (SAEs) related to the investigational device
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.
Time frame: 7 days
Serious Adverse Events (SAEs) not related to the investigational device or procedure
The incidence of SAEs occurring while connected to the device that are not deemed related to the investigational device or procedure will be assessed.
Time frame: 7 days
Clinically significant changes in hematology indices
Clinically significant changes in hematology indices will be evaluated to monitor potential safety concerns.
Time frame: 7 days
Clinically significant changes in chemistry indices
Clinically significant changes in chemistry indices will be evaluated to monitor potential safety concerns.
Time frame: 7 days
Device deficiencies and malfunctions
Any deficiencies or malfunctions of the PATH EX CycloPE® device, including procedural or technical issues, will be recorded and analyzed.
Time frame: 7 days
Clinical and laboratory adverse events (AEs)
The incidence of all clinical and laboratory adverse events (AEs) occurring up to 7 days post-enrollment will be assessed for potential safety concerns.
Time frame: 7 days
Pathogen reduction in the bloodstream
Pathogen reduction will be evaluated by measuring the increase in time to positivity (TTP) of blood samples before versus after treatment with the PATH EX CycloPE® device. Only blood samples with a measurable positive TTP before treatment will be included in this analysis.
Time frame: 7 days
Plan to share: No
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This study is active, not recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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