Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04260789
Recruitment Status : Recruiting
First Posted : February 7, 2020
Last Update Posted : December 17, 2021
Sponsor:
Collaborators:
ExThera Medical Corporation
Vivantes Klinikum Neukölln
Information provided by (Responsible Party):
ExThera Medical Europe BV

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

Condition or disease Intervention/treatment Phase
Bloodstream Infection Device: Seraph 100,The Microbind Affinity Blood Filter Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 232 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Open randomized post-market trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 19, 2020
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : August 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Arm Intervention/treatment
Treatment
Treatment with Seraph Filter
Device: Seraph 100,The Microbind Affinity Blood Filter
Treatment with Seraph 100 in one arm

No Intervention: Control



Primary Outcome Measures :
  1. Reduction of pathogens load [ Time Frame: 4,5 hours +/- 30 min ]
    Reduction of pathogens load from the bloodstream during treatment


Secondary Outcome Measures :
  1. All-cause mortality [ Time Frame: 90 days ]
    All-cause mortality

  2. Persistence/Recurrence of bacteremia [ Time Frame: Day 1, day 2, day 7 ]
    Measure persistence recurrence of bacteremia

  3. Persistence/Recurrence of sepsis [ Time Frame: Daily during ICU stay or at least day 1, day 2, day 7 ]
    Measure persistence recurrence of sepsis

  4. Organ dysfunction-free days [ Time Frame: Daily during ICU stay or at least day 1, day 2, day 7 ]
    Measure organ dysfunction free days

  5. Change of Intensive Care Unit (ICU) complications [ Time Frame: Daily during ICU stay or at least day 1, day 2, day 7 ]
    Reduction of ICU complications

  6. Ventilator-free days (VFDs) [ Time Frame: Daily during ICU stay or at least day 1, day 2, day 7 ]
    VFD

  7. Length of stay (LOS) at ICU and hospital ward [ Time Frame: During ICU and hospital ward stay or at least day 1, day 2, day 7 ]
    Measure LOS


Other Outcome Measures:
  1. Treatment emergent adverse events [ Time Frame: Occurrence within the 90 days follow-up period ]
    N (%) of patients with treatment emergent adverse events



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04260789


Contacts
Layout table for location contacts
Contact: Carla Kikken-Jussen +31438200399 carla@extheramedical.com

Locations
Show Show 25 study locations
Sponsors and Collaborators
ExThera Medical Europe BV
ExThera Medical Corporation
Vivantes Klinikum Neukölln
Investigators
Layout table for investigator information
Principal Investigator: Herwig Gerlach, Prof. Vivantes Klinikum Neukölln
Layout table for additonal information
Responsible Party: ExThera Medical Europe BV
ClinicalTrials.gov Identifier: NCT04260789    
Other Study ID Numbers: CP015
First Posted: February 7, 2020    Key Record Dates
Last Update Posted: December 17, 2021
Last Verified: December 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Infections
Communicable Diseases
Sepsis
Disease Attributes
Pathologic Processes
Systemic Inflammatory Response Syndrome
Inflammation