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

Bloodstream Infection Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04260789
• Other study ID #: CP015
• Status: Recruiting
• Phase: N/A
• Start date: August 19, 2020
• Est. completion date: August 1, 2022

Study information

• Verified date: December 2021
• Source: ExThera Medical Europe BV
• Contact: Carla Kikken-Jussen
• Phone: +31438200399
• Email: carla[@]extheramedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 232
• Est. completion date: August 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Bloodstream Infection
• Communicable Diseases
• Infections
• Sepsis

Intervention

Device:
• Seraph 100,The Microbind Affinity Blood Filter
Treatment with Seraph 100 in one arm

Locations

Country	Name	City	State
Austria	Medical University of Innsbruck	Innsbruck
Belgium	Middelheim Hospital	Antwerp
Belgium	Hôpital Erasme	Brussels
France	CHU Bocage Central	Dijon
France	Hospices Civils de Lyon	Lyon
France	Nouvel Hopital Civil	Strasbourg
Germany	Klinikum Aschaffenburg-Alzenau	Aschaffenburg
Germany	Vivantes Klinikum Neukölln	Berlin
Germany	Städtisches Klinikum Braunschweig GmbH	Braunschweig
Germany	Universität Witten-Herdecke	Cologne
Germany	Universitätsklinikum Essen (AöR)	Essen
Germany	University Hospital Frankfurt	Frankfurt
Germany	Universitätsmedizin Greifswald	Greifswald
Germany	Asklepios Hospital St. Georg	Hamburg
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Universität Rostock	Rostock
Italy	Azienda Usl Toscana Centro	Florence
Italy	University Hospital, Pisa	Pisa
Italy	A.Gemelli University Hospital	Roma
Netherlands	Ziekenhuis Gelderse Vallei	Ede
Netherlands	Medisch Spectrum Twente	Enschede
Poland	Jagiellonia University	Kraków
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Hospital Clinico San Carlos	Madrid
United Kingdom	Royal Surrey NHS Foundation Trust	London

Sponsors (3)

Lead Sponsor	Collaborator
ExThera Medical Europe BV	ExThera Medical Corporation, Vivantes Klinikum Neukölln

Countries where clinical trial is conducted

Austria,  Belgium,  France,  Germany,  Italy,  Netherlands,  Poland,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Treatment emergent adverse events	N (%) of patients with treatment emergent adverse events	Occurrence within the 90 days follow-up period
Primary	Reduction of pathogens load	Reduction of pathogens load from the bloodstream during treatment	4,5 hours +/- 30 min
Secondary	All-cause mortality	All-cause mortality	90 days
Secondary	Persistence/Recurrence of bacteremia	Measure persistence recurrence of bacteremia	Day 1, day 2, day 7
Secondary	Persistence/Recurrence of sepsis	Measure persistence recurrence of sepsis	Daily during ICU stay or at least day 1, day 2, day 7
Secondary	Organ dysfunction-free days	Measure organ dysfunction free days	Daily during ICU stay or at least day 1, day 2, day 7
Secondary	Change of Intensive Care Unit (ICU) complications	Reduction of ICU complications	Daily during ICU stay or at least day 1, day 2, day 7
Secondary	Ventilator-free days (VFDs)	VFD	Daily during ICU stay or at least day 1, day 2, day 7
Secondary	Length of stay (LOS) at ICU and hospital ward	Measure LOS	During ICU and hospital ward stay or at least day 1, day 2, day 7