Initial Feasibility Study of the CycloPE® Device

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:

1. Body temperature > 101°F (38.3°C) or < 96.8°F (36°C);
2. Heart rate > 90 beats per minute;
3. Respiratory rate > 20 breaths per minute;
4. 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 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:

1. IV antibiotic treatment initiated > 48 hours before baseline screening has been deemed ineffective based on the clinical judgment of the investigator.
2. 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.
3. 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.