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

Last updated: December 16, 2021
Sponsor: ExThera Medical Europe BV
Overall Status: Active - Recruiting

Phase

N/A

Condition

Soft Tissue Infections

Treatment

N/A

Clinical Study ID

NCT04260789
CP015
  • Ages 18-90
  • All Genders
  • Accepts Healthy Volunteers

Study 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

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  1. Subject is currently participating in another clinical investigation
  2. Pregnant or nursing subjects and those who plan pregnancy during the clinicalinvestigation follow-up period
  3. Presence of comorbid conditions, or other medical, social, or psychological conditionsthat, in the investigator's opinion, could limit the subject's ability to participatein the clinical investigation or to comply with follow-up requirements, or impact thescientific 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 Design

Total Participants: 232
Study Start date:
August 19, 2020
Estimated Completion Date:
August 01, 2022

Study 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.

Connect with a study center

  • Medical University of Innsbruck

    Innsbruck,
    Austria

    Site Not Available

  • Middelheim Hospital

    Antwerp,
    Belgium

    Active - Recruiting

  • Hôpital Erasme

    Brussels,
    Belgium

    Site Not Available

  • CHU Bocage Central

    Dijon,
    France

    Site Not Available

  • Hospices Civils de Lyon

    Lyon,
    France

    Active - Recruiting

  • Nouvel Hopital Civil

    Strasbourg,
    France

    Site Not Available

  • Klinikum Aschaffenburg-Alzenau

    Aschaffenburg,
    Germany

    Site Not Available

  • Vivantes Klinikum Neukölln

    Berlin,
    Germany

    Site Not Available

  • Städtisches Klinikum Braunschweig GmbH

    Braunschweig,
    Germany

    Active - Recruiting

  • Universität Witten-Herdecke

    Cologne,
    Germany

    Active - Recruiting

  • Universitätsklinikum Essen (AöR)

    Essen,
    Germany

    Active - Recruiting

  • University Hospital Frankfurt

    Frankfurt,
    Germany

    Active - Recruiting

  • Universitätsmedizin Greifswald

    Greifswald,
    Germany

    Site Not Available

  • Asklepios Hospital St. Georg

    Hamburg,
    Germany

    Site Not Available

  • Medizinische Hochschule Hannover

    Hannover,
    Germany

    Site Not Available

  • Universität Rostock

    Rostock,
    Germany

    Active - Recruiting

  • Azienda Usl Toscana Centro

    Florence,
    Italy

    Active - Recruiting

  • University Hospital, Pisa

    Pisa,
    Italy

    Site Not Available

  • A.Gemelli University Hospital

    Roma,
    Italy

    Site Not Available

  • Ziekenhuis Gelderse Vallei

    Ede,
    Netherlands

    Site Not Available

  • Medisch Spectrum Twente

    Enschede,
    Netherlands

    Active - Recruiting

  • Jagiellonia University

    Kraków,
    Poland

    Active - Recruiting

  • Hospital Universitari Vall d'Hebron

    Barcelona,
    Spain

    Site Not Available

  • Hospital Clinico San Carlos

    Madrid,
    Spain

    Site Not Available

  • Royal Surrey NHS Foundation Trust

    London,
    United Kingdom

    Active - Recruiting

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