Safety and Performance Evaluation of Seraph 100 Microbind Affinity Blood Filter (Seraph 100) in the reduction of pathogen load from the blood in septic patients with suspected, life-threatening bloodstream infectio

Phase 2

Recruiting

Conditions: A41
Other sepsis

Registration Number: DRKS00022186

Lead Sponsor: ExThera Medical Corporation

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 232

Inclusion Criteria

1. Patients with sepsis and suspected bloodstream infection
2. Be = 18 years old and =90 years old
3. Adults receiving IV antibiotic therapy
4. Increase of at least two points of the Sequential Organ Failure Assessment (SOFA) score
5. Subjects that presents Procalcitonin (PCT) levels >0,5 ng/m

Exclusion Criteria

1. Subject is currently participating in another clinical investigation
2. Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period
3. Presence of comorbid conditions, or other medical, social, or psychological conditions that, in the investigator’s opinion, could limit the subject’s ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results
4. Antibiotic IV treatment > 12 h before screening
5. Have neutropenia (absolute neutrophil count <500 cells/uL
6. Have Child-Pugh Class C cirrhosis
7. Have platelet count <30.000/uL
8. Contraindications for heparin sodium for injection
9. Subjects demonstrating any contraindication for this treatment as described in the IF

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction of pathogens load from the bloodstream during treatment

Secondary Outcome Measures

Name	Time	Method
All-cause mortality<br>Time frame: [ 90 Days]<br>• Persistence/Recurrence of bacteremia<br>Time frame: [ Day 1, Day 2, Day 7]<br>• Persistence/Recurrence of sepsis<br>Time frame: [ Daily during ICU stay or at least Day 1, Day 2, Day7]<br>Organ dysfunction-free days<br>Time frame: [ Daily during ICU stay or at least Day 1, Day 2, Day 7 ]<br>• Reduction of Intensive Care Unit (ICU) complications<br>Time frame: [ Daily during ICU stay ]<br>• Ventilator-free days (VFDs)<br>Time frame: [ Daily during ICU stay or at least Day 1, Day 2, Day 7 ]<br>• Length of stay (LOS) at ICU and hospital ward