Reduction of Pathogen Load From the Blood in Septic Patients With Suspected, Life-threatening Bloodstream Infection

NCT04260789 | Unknown

• 1 other identifier: CP015
• Study Type: interventional
• Target: 232
• Locations: 9 countries
• Sites: 25

Brief Summary

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 infection

Conditions

Bloodstream Infection

Outcome Measures

Primary Outcomes (1)

• Reduction of pathogens load

  Reduction of pathogens load from the bloodstream during treatment

  4,5 hours +/- 30 min

Secondary Outcomes (7)

• All-cause mortality

  90 days

• Persistence/Recurrence of bacteremia

  Day 1, day 2, day 7

• Persistence/Recurrence of sepsis

  Daily during ICU stay or at least day 1, day 2, day 7

• Organ dysfunction-free days

  Daily during ICU stay or at least day 1, day 2, day 7

• Change of Intensive Care Unit (ICU) complications

  Daily during ICU stay or at least day 1, day 2, day 7

Other Outcomes (1)

• Treatment emergent adverse events

  Occurrence within the 90 days follow-up period

Study Arms (2)

Treatment

OTHER

Treatment with Seraph Filter

Device: Seraph 100,The Microbind Affinity Blood Filter

Control

NO INTERVENTION

Interventions

Seraph 100,The Microbind Affinity Blood Filter DEVICE

Treatment with Seraph 100 in one arm

Treatment

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with sepsis and suspected bloodstream infection
• Be ≥ 18 years old and ≤ 90 years old
• Adults receiving IV antibiotic therapy
• Increase of at least two points of the Sequential Organ Failure Assessment (SOFA) score
• Subjects that presents Procalcitonin (PCT) levels \> 0,5 ng/mL

You may not qualify if:

• Subject is currently participating in another clinical investigation
• Pregnant or nursing subjects and those who plan pregnancy during the clinical investigation follow-up period
• 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
• The first dose of the current antibiotic therapy was \> 24 h before screening
• Have Child-Pugh Class C cirrhosis
• Have platelet count \< 30.000/uL
• Contraindications for heparin sodium for injection
• Subjects demonstrating any contraindication for this treatment as described in the IFU

Sponsors & Collaborators

• ExThera Medical Europe BV: lead
• ExThera Medical Corporation: collaborator
• Vivantes Clinic Neukölln: collaborator

Study Sites (25)

Medical University of Innsbruck

Innsbruck, Austria

ACTIVE NOT RECRUITING

Middelheim Hospital

Antwerp, Belgium

RECRUITING

Hôpital Erasme

Brussels, Belgium

ACTIVE NOT RECRUITING

CHU Bocage Central

Dijon, France

ACTIVE NOT RECRUITING

Hospices Civils de Lyon

Lyon, France

RECRUITING

Nouvel Hopital Civil

Strasbourg, France

ACTIVE NOT RECRUITING

Klinikum Aschaffenburg-Alzenau

Aschaffenburg, Germany

ACTIVE NOT RECRUITING

Vivantes Klinikum Neukölln

Berlin, Germany

ACTIVE NOT RECRUITING

Städtisches Klinikum Braunschweig GmbH

Braunschweig, Germany

RECRUITING

Universität Witten-Herdecke

Cologne, Germany

RECRUITING

Universitätsklinikum Essen (AöR)

Essen, Germany

RECRUITING

University Hospital Frankfurt

Frankfurt, Germany

RECRUITING

Universitätsmedizin Greifswald

Greifswald, Germany

ACTIVE NOT RECRUITING

Asklepios Hospital St. Georg

Hamburg, Germany

NOT YET RECRUITING

Medizinische Hochschule Hannover

Hanover, Germany

ACTIVE NOT RECRUITING

Universität Rostock

Rostock, Germany

RECRUITING

Azienda Usl Toscana Centro

Florence, Italy

RECRUITING

University Hospital, Pisa

Pisa, Italy

NOT YET RECRUITING

A.Gemelli University Hospital

Roma, Italy

ACTIVE NOT RECRUITING

Ziekenhuis Gelderse Vallei

Ede, Netherlands

ACTIVE NOT RECRUITING

Medisch Spectrum Twente

Enschede, Netherlands

RECRUITING

Jagiellonia University

Krakow, Poland

RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, Spain

ACTIVE NOT RECRUITING

Hospital Clinico San Carlos

Madrid, Spain

ACTIVE NOT RECRUITING

Royal Surrey NHS Foundation Trust

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Herwig Gerlach, Prof.

  Vivantes Clinic Neukölln

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carla Kikken-Jussen

CONTACT

+31438200399; carla@extheramedical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Open randomized post-market trial

Study Record Dates

• First Submitted: February 5, 2020
• First Posted: February 7, 2020
• Study Start: August 19, 2020
• Primary Completion: March 1, 2022
• Study Completion: August 1, 2022
• Last Updated: December 17, 2021

Record last verified: 2021-12

Locations

AU (1); NL (2); ES (2); FR (3); BE (2); DE (10); PL (1); GB (1); IT (3)