Bloodstream Infection
Conditions
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.
Interventions
DEVICESeraph 100,The Microbind Affinity Blood Filter
Treatment with Seraph 100 in one arm
Sponsors
ExThera Medical Corporation
Vivantes Clinic Neukölln
ExThera Medical Europe BV
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open randomized post-market trial
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of pathogens load | 4,5 hours +/- 30 min | Reduction of pathogens load from the bloodstream during treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality | 90 days | All-cause mortality |
| Persistence/Recurrence of bacteremia | Day 1, day 2, day 7 | Measure persistence recurrence of bacteremia |
| Persistence/Recurrence of sepsis | Daily during ICU stay or at least day 1, day 2, day 7 | Measure persistence recurrence of sepsis |
| Change of Intensive Care Unit (ICU) complications | Daily during ICU stay or at least day 1, day 2, day 7 | Reduction of ICU complications |
| Ventilator-free days (VFDs) | Daily during ICU stay or at least day 1, day 2, day 7 | VFD |
| Length of stay (LOS) at ICU and hospital ward | During ICU and hospital ward stay or at least day 1, day 2, day 7 | Measure LOS |
| Organ dysfunction-free days | Daily during ICU stay or at least day 1, day 2, day 7 | Measure organ dysfunction free days |
Other
| Measure | Time frame | Description |
|---|---|---|
| Treatment emergent adverse events | Occurrence within the 90 days follow-up period | N (%) of patients with treatment emergent adverse events |
Countries
Austria, Belgium, France, Germany, Italy, Netherlands, Poland, Spain, United Kingdom
Contacts
Primary ContactCarla Kikken-Jussen
Outcome results
None listed