Clinical trial NCT04260789: Reduction of Pathogen Load From the Blood in Septic Patients With Suspected, Life-threatening Bloodstream Infection
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bloodstream Infection
Lead sponsor: ExThera Medical Europe BV
Sponsor class: INDUSTRY
Collaborators: name: ExThera Medical Corporation
name: Vivantes Clinic Neukölln
First posted: 2020-02-07
Enrollment: 232
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Open randomized post-market trial
Primary purpose: TREATMENT

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

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.

Eligibility 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

Primary outcomes:
measure: Reduction of pathogens load
timeFrame: 4,5 hours +/- 30 min
Secondary outcomes:
measure: All-cause mortality
timeFrame: 90 days
measure: Persistence/Recurrence of bacteremia
timeFrame: Day 1, day 2, day 7
measure: Persistence/Recurrence of sepsis
timeFrame: Daily during ICU stay or at least day 1, day 2, day 7
measure: Organ dysfunction-free days
timeFrame: Daily during ICU stay or at least day 1, day 2, day 7
measure: Change of Intensive Care Unit (ICU) complications
timeFrame: Daily during ICU stay or at least day 1, day 2, day 7
measure: Ventilator-free days (VFDs)
timeFrame: Daily during ICU stay or at least day 1, day 2, day 7
measure: Length of stay (LOS) at ICU and hospital ward
timeFrame: During ICU and hospital ward stay or at least day 1, day 2, day 7
Other outcomes:
measure: Treatment emergent adverse events
timeFrame: Occurrence within the 90 days follow-up period
Locations:
city: Innsbruck
country: Austria
facility: Medical University of Innsbruck
city: Antwerp
country: Belgium
facility: Middelheim Hospital
city: Brussels
country: Belgium
facility: Hôpital Erasme
city: Dijon
country: France
facility: CHU Bocage Central
city: Lyon
country: France
facility: Hospices Civils de Lyon
city: Strasbourg
country: France
facility: Nouvel Hopital Civil
city: Aschaffenburg
country: Germany
facility: Klinikum Aschaffenburg-Alzenau
city: Berlin
country: Germany
facility: Vivantes Klinikum Neukölln
city: Braunschweig
country: Germany
facility: Städtisches Klinikum Braunschweig GmbH
city: Cologne
country: Germany
facility: Universität Witten-Herdecke
city: Essen
country: Germany
facility: Universitätsklinikum Essen (AöR)
city: Frankfurt
country: Germany
facility: University Hospital Frankfurt
city: Greifswald
country: Germany
facility: Universitätsmedizin Greifswald
city: Hamburg
country: Germany
facility: Asklepios Hospital St. Georg
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Rostock
country: Germany
facility: Universität Rostock
city: Florence
country: Italy
facility: Azienda Usl Toscana Centro
city: Pisa
country: Italy
facility: University Hospital, Pisa
city: Roma
country: Italy
facility: A.Gemelli University Hospital
city: Ede
country: Netherlands
facility: Ziekenhuis Gelderse Vallei
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
city: Kraków
country: Poland
facility: Jagiellonia University
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: London
country: United Kingdom
facility: Royal Surrey NHS Foundation Trust
Study officials:
affiliation: Vivantes Clinic Neukölln
name: Herwig Gerlach, Prof.
role: PRINCIPAL_INVESTIGATOR
References: