Status:
ACTIVE_NOT_RECRUITING
Initial Feasibility Study of the CycloPE® Device
Lead Sponsor:
PATH EX, Inc.
Conditions:
Sepsis
Infection
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 parti...
Detailed Description
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-a...
Eligibility Criteria
Inclusion
- Hospitalized adults (age \>= 18 years, male and female) 2. Receiving IV antibiotic therapy 3. 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 4. Clinical evidence of new organ dysfunction 5. Procalcitonin (PCT) levels ≥ 0.5 ng/mL
Exclusion
- 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:
- 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.
- 11\. Participated in an interventional clinical study within 28 days prior to Day 0 or undergoing treatment anticipated to require significant blood draws 12. Have been previously enrolled in this clinical trial 13. History of or known hypercoagulable state 14. Known history of a condition that may result in an increased risk for thrombosis 15. Any other condition, that in the opinion of the investigator, would preclude the subject from being a suitable candidate for enrollment 16. Unable to obtain informed consent from either patient or legally authorized representative 17. Patients who cannot tolerate placement of double-lumen catheter 18. Suspected or confirmed SARS-CoV-2 infection (COVID-19) that cannot be resolved before administration of investigational device.
Key Trial Info
Start Date :
June 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 15 2025
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06970899
Start Date
June 11 2024
End Date
May 15 2025
Last Update
May 14 2025
Active Locations (1)
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1
Erebuni Medical Cener
Yerevan, Armenia, Armenia, 0087