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

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

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

Study Overview

• Status: Recruiting
• Conditions: Bloodstream Infection
• Intervention / Treatment: Device: Seraph 100,The Microbind Affinity Blood Filter

Detailed Description

With the lack of effective antibiotics for many bloodstream infections, and limited new anti-infectives in development, there is a significant unmet need for new approaches that can help treat drug-resistant infections, especially in patients at high risk. There is an unmet need for a safe and broad-spectrum hemoperfusion therapy that can quickly reduce bacterial load and shorten the duration of bacteremia, preferably without the need to first identifying the type of bacteria present in the blood. There is an emerging need to increase the efficacy of effective antibiotics, e.g., by using hemadsorption as adjunctive therapy, to by quickly reducing bacterial load while scavenging toxins released from bacteria. Finally, there is a medical growing need for an alternative therapy when no effective antibiotic is available.

Seraph 100 Microbind Affinity Blood Filter is used to reduce pathogen load during bloodstream infection. Bacteremia or bloodstream infection, also called BSI, occurs when a bacterial infection elsewhere in the body enters the bloodstream. This clinical condition can quickly become life-threatening and progress to sepsis. Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection (Singer et al., 2016).When sepsis occurs with extremely low blood pressure, it's called septic shock. Septic shock is fatal in many cases.

Sepsis can be triggered by many types of bacteremia although the exact source of the infection often cannot be determined. Some of the most common infections that lead to BSI are lung infections (i.e. pneumonia) and infections in the abdominal area. Patients who are already in the hospital for something else, such as a surgery, are at a higher risk of developing BSI. These infections are even more dangerous when the bacteria are already resistant to antibiotics. The National Institutes of Health (NIH) estimates that over 1 million Americans get sepsis each year. Between 28 and 50 percent of these patients may die from the condition.

• Study Type: Interventional
• Enrollment (Anticipated): 232
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Carla Kikken-Jussen; Phone Number: +31438200399; Email: carla@extheramedical.com

Study Locations

• Austria
  • Innsbruck, Austria
    • Active, not recruiting
    • Medical University of Innsbruck
• Belgium
  • Antwerp, Belgium
    • Recruiting
    • Middelheim Hospital
    • Contact: Rogier Nieuwendijk, Dr.
    • Principal Investigator: Rogier Nieuwendijk, Dr.
  • Brussels, Belgium
    • Active, not recruiting
    • Hôpital Erasme
• France
  • Dijon, France
    • Active, not recruiting
    • CHU Bocage Central
  • Lyon, France
    • Recruiting
    • Hospices Civils de Lyon
    • Contact: Thomas Rimmelé, Prof.
    • Principal Investigator: Thomas Rimmelé, Prof.
  • Strasbourg, France
    • Active, not recruiting
    • Nouvel Hôpital Civil
• Germany
  • Aschaffenburg, Germany
    • Active, not recruiting
    • Klinikum Aschaffenburg-Alzenau
  • Berlin, Germany
    • Active, not recruiting
    • Vivantes Klinikum Neukölln
  • Braunschweig, Germany
    • Recruiting
    • Städtisches Klinikum Braunschweig GmbH
    • Contact: Jan Kielstein, Prof.
    • Principal Investigator: Jan Kielstein, Prof.
  • Cologne, Germany
    • Recruiting
    • Universität Witten-Herdecke
    • Contact: Achim Jörres, Prof.
    • Principal Investigator: Achim Jörres, Dr.
  • Essen, Germany
    • Recruiting
    • Universitatsklinikum Essen (Aor)
    • Contact: Bartosz Tyczynski, Dr.
    • Principal Investigator: Bartosz Tyczynski, Dr.
  • Frankfurt, Germany
    • Recruiting
    • University Hospital Frankfurt
    • Contact: Christoph Betz, Dr.
    • Principal Investigator: Christoph Betz
  • Greifswald, Germany
    • Active, not recruiting
    • Universitätsmedizin Greifswald
  • Hamburg, Germany
    • Not yet recruiting
    • Asklepios Hospital St. Georg
    • Contact: Berthold Bein, Prof.
    • Principal Investigator: Berthold Bein, Prof.
  • Hannover, Germany
    • Active, not recruiting
    • Medizinische Hochschule Hannover
  • Rostock, Germany
    • Recruiting
    • Universität Rostock
    • Contact: Steffen Mitzner, Prof.
    • Principal Investigator: Steffen Mitzner, Prof.
• Italy
  • Florence, Italy
    • Recruiting
    • Azienda USL Toscana Centro
    • Contact: Vittorio Pavoni, Dr.
    • Principal Investigator: Vittorio Pavoni, Dr.
  • Pisa, Italy
    • Not yet recruiting
    • University Hospital, Pisa
    • Contact: Francesco Forfori, Prof.
    • Principal Investigator: Francesco Forfori, Prof.
  • Roma, Italy
    • Active, not recruiting
    • A.Gemelli University Hospital
• Netherlands
  • Ede, Netherlands
    • Active, not recruiting
    • Ziekenhuis Gelderse Vallei
  • Enschede, Netherlands
    • Recruiting
    • Medisch Spectrum Twente
    • Contact: Albertus Beishuizen, Dr.
    • Principal Investigator: Albertus Beishuizen, Dr.
• Poland
  • Kraków, Poland
    • Recruiting
    • Jagiellonia University
    • Contact: Jaroslaw B. Garlicki, Dr.
    • Principal Investigator: Jaroslaw B. Garlicki, Dr.
• Spain
  • Barcelona, Spain
    • Active, not recruiting
    • Hospital Universitari Vall d'Hebron
  • Madrid, Spain
    • Active, not recruiting
    • Hospital Clinico San Carlos
• United Kingdom
  • London, United Kingdom
    • Recruiting
    • Royal Surrey NHS Foundation Trust
    • Contact: Lui Forni, Prof.
    • Principal Investigator: Lui Forni, Prof.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 86 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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/mL

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. The first dose of the current antibiotic therapy was > 24 h before screening
5. Have Child-Pugh Class C cirrhosis
6. Have platelet count < 30.000/uL
7. Contraindications for heparin sodium for injection
8. Subjects demonstrating any contraindication for this treatment as described in the IFU

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Other: Treatment; Treatment with Seraph Filter	Device: Seraph 100,The Microbind Affinity Blood Filter; Treatment with Seraph 100 in one arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of pathogens load	Reduction of pathogens load from the bloodstream during treatment	4,5 hours +/- 30 min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	All-cause mortality	90 days
Persistence/Recurrence of bacteremia	Measure persistence recurrence of bacteremia	Day 1, day 2, day 7
Persistence/Recurrence of sepsis	Measure persistence recurrence of sepsis	Daily during ICU stay or at least day 1, day 2, day 7
Organ dysfunction-free days	Measure organ dysfunction free days	Daily during ICU stay or at least day 1, day 2, day 7
Change of Intensive Care Unit (ICU) complications	Reduction of ICU complications	Daily during ICU stay or at least day 1, day 2, day 7
Ventilator-free days (VFDs)	VFD	Daily during ICU stay or at least day 1, day 2, day 7
Length of stay (LOS) at ICU and hospital ward	Measure LOS	During ICU and hospital ward stay or at least day 1, day 2, day 7

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment emergent adverse events	N (%) of patients with treatment emergent adverse events	Occurrence within the 90 days follow-up period

Collaborators and Investigators

• Sponsor: ExThera Medical Europe BV
• Collaborators: ExThera Medical Corporation; Vivantes Clinic Neukölln
• Investigators: Principal Investigator: Herwig Gerlach, Prof., Vivantes Clinic Neukölln

Study record dates

Study Major Dates

• Study Start (Actual): August 19, 2020
• Primary Completion (Anticipated): March 1, 2022
• Study Completion (Anticipated): August 1, 2022

Study Registration Dates

• First Submitted: February 5, 2020
• First Submitted That Met QC Criteria: February 5, 2020
• First Posted (Actual): February 7, 2020

Study Record Updates

• Last Update Posted (Actual): December 17, 2021
• Last Update Submitted That Met QC Criteria: December 16, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Systemic Inflammatory Response Syndrome; Inflammation; Disease Attributes; Sepsis; Infections; Communicable Diseases
• Other Study ID Numbers: CP015

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No