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

  • STATUS
    Recruiting
  • days left to enroll
    30
  • participants needed
    232
  • sponsor
    ExThera Medical Europe BV
Updated on 23 December 2021
Accepts healthy volunteers

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

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.

Details
Condition Bloodstream Infection
Treatment Seraph 100,The Microbind Affinity Blood Filter
Clinical Study IdentifierNCT04260789
SponsorExThera Medical Europe BV
Last Modified on23 December 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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