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

NCT ID: NCT04260789

Last Updated: 2021-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

232 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-19

Study Completion Date

2022-08-01

Brief Summary

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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

Detailed Description

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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.

Conditions

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Bloodstream Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Open randomized post-market trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

Treatment with Seraph Filter

Group Type OTHER

Seraph 100,The Microbind Affinity Blood Filter

Intervention Type DEVICE

Treatment with Seraph 100 in one arm

Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Seraph 100,The Microbind Affinity Blood Filter

Treatment with Seraph 100 in one arm

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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ExThera Medical Corporation

INDUSTRY

Sponsor Role collaborator

Vivantes Clinic Neukölln

OTHER

Sponsor Role collaborator

ExThera Medical Europe BV

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Herwig Gerlach, Prof.

Role: PRINCIPAL_INVESTIGATOR

Vivantes Clinic Neukölln

Locations

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Medical University of Innsbruck

Innsbruck, , Austria

Site Status ACTIVE_NOT_RECRUITING

Middelheim Hospital

Antwerp, , Belgium

Site Status RECRUITING

Hôpital Erasme

Brussels, , Belgium

Site Status ACTIVE_NOT_RECRUITING

CHU Bocage Central

Dijon, , France

Site Status ACTIVE_NOT_RECRUITING

Hospices Civils de Lyon

Lyon, , France

Site Status RECRUITING

Nouvel Hopital Civil

Strasbourg, , France

Site Status ACTIVE_NOT_RECRUITING

Klinikum Aschaffenburg-Alzenau

Aschaffenburg, , Germany

Site Status ACTIVE_NOT_RECRUITING

Vivantes Klinikum Neukölln

Berlin, , Germany

Site Status ACTIVE_NOT_RECRUITING

Städtisches Klinikum Braunschweig GmbH

Braunschweig, , Germany

Site Status RECRUITING

Universität Witten-Herdecke

Cologne, , Germany

Site Status RECRUITING

Universitätsklinikum Essen (AöR)

Essen, , Germany

Site Status RECRUITING

University Hospital Frankfurt

Frankfurt, , Germany

Site Status RECRUITING

Universitätsmedizin Greifswald

Greifswald, , Germany

Site Status ACTIVE_NOT_RECRUITING

Asklepios Hospital St. Georg

Hamburg, , Germany

Site Status NOT_YET_RECRUITING

Medizinische Hochschule Hannover

Hanover, , Germany

Site Status ACTIVE_NOT_RECRUITING

Universität Rostock

Rostock, , Germany

Site Status RECRUITING

Azienda Usl Toscana Centro

Florence, , Italy

Site Status RECRUITING

University Hospital, Pisa

Pisa, , Italy

Site Status NOT_YET_RECRUITING

A.Gemelli University Hospital

Roma, , Italy

Site Status ACTIVE_NOT_RECRUITING

Ziekenhuis Gelderse Vallei

Ede, , Netherlands

Site Status ACTIVE_NOT_RECRUITING

Medisch Spectrum Twente

Enschede, , Netherlands

Site Status RECRUITING

Jagiellonia University

Krakow, , Poland

Site Status RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Site Status ACTIVE_NOT_RECRUITING

Hospital Clinico San Carlos

Madrid, , Spain

Site Status ACTIVE_NOT_RECRUITING

Royal Surrey NHS Foundation Trust

London, , United Kingdom

Site Status RECRUITING

Countries

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Austria Belgium France Germany Italy Netherlands Poland Spain United Kingdom

Central Contacts

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Carla Kikken-Jussen

Role: CONTACT

Phone: +31438200399

Email: [email protected]

Facility Contacts

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Rogier Nieuwendijk, Dr.

Role: primary

Thomas Rimmelé, Prof.

Role: primary

Jan Kielstein, Prof.

Role: primary

Achim Jörres, Prof.

Role: primary

Bartosz Tyczynski, Dr.

Role: primary

Christoph Betz, Dr.

Role: primary

Berthold Bein, Prof.

Role: primary

Steffen Mitzner, Prof.

Role: primary

Vittorio Pavoni, Dr.

Role: primary

Francesco Forfori, Prof.

Role: primary

Albertus Beishuizen, Dr.

Role: primary

Jaroslaw B. Garlicki, Dr.

Role: primary

Lui Forni, Prof.

Role: primary

Other Identifiers

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CP015

Identifier Type: -

Identifier Source: org_study_id