Bloodstream InfectionNCT04260789
Reduction of Pathogen Load From the Blood in Septic Patients With Suspected, Life-threatening Bloodstream Infection
A study testing Seraph 100,The Microbind Affinity Blood Filter in people with Bloodstream Infection, run by ExThera Medical Europe BV at 25 sites in 9 countries.
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 Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Bloodstream Infection
- What is being tested?
- Seraph 100,The Microbind Affinity Blood Filter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 232 participants
- Where
- 25 sitesin 9 countries
- Study dates
- 19 Aug 2020to 1 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
25 sites in 9 countries.
25 sites in 9 countries
Germany10 sites, 6 recruiting
- Active, not recruiting
Klinikum Aschaffenburg-Alzenau
Aschaffenburg
- Active, not recruiting
Vivantes Klinikum Neukölln
Berlin
- Recruiting
Städtisches Klinikum Braunschweig GmbH
Braunschweig
Jan Kielstein, Prof.
Jan Kielstein, Prof.
- Recruiting
Universität Witten-Herdecke
Cologne
Achim Jörres, Prof.
Achim Jörres, Dr.
- Recruiting
Universitätsklinikum Essen (AöR)
Essen
Bartosz Tyczynski, Dr.
Bartosz Tyczynski, Dr.
- Recruiting
University Hospital Frankfurt
Frankfurt
Christoph Betz, Dr.
Christoph Betz
- Active, not recruiting
Universitätsmedizin Greifswald
Greifswald
- Not yet recruiting
Asklepios Hospital St. Georg
Hamburg
Berthold Bein, Prof.
Berthold Bein, Prof.
- Active, not recruiting
Medizinische Hochschule Hannover
Hanover
- Recruiting
Universität Rostock
Rostock
Steffen Mitzner, Prof.
Steffen Mitzner, Prof.
France3 sites, 1 recruiting
- Active, not recruiting
CHU Bocage Central
Dijon
- Recruiting
Hospices Civils de Lyon
Lyon
Thomas Rimmelé, Prof.
Thomas Rimmelé, Prof.
- Active, not recruiting
Nouvel Hopital Civil
Strasbourg
Italy3 sites, 2 recruiting
- Recruiting
Azienda Usl Toscana Centro
Florence
Vittorio Pavoni, Dr.
Vittorio Pavoni, Dr.
- Not yet recruiting
University Hospital, Pisa
Pisa
Francesco Forfori, Prof.
Francesco Forfori, Prof.
- Active, not recruiting
A.Gemelli University Hospital
Roma
Belgium2 sites, 1 recruiting
- Recruiting
Middelheim Hospital
Antwerp
Rogier Nieuwendijk, Dr.
Rogier Nieuwendijk, Dr.
- Active, not recruiting
Hôpital Erasme
Brussels
Netherlands2 sites, 1 recruiting
- Active, not recruiting
Ziekenhuis Gelderse Vallei
Ede
- Recruiting
Medisch Spectrum Twente
Enschede
Albertus Beishuizen, Dr.
Albertus Beishuizen, Dr.
Spain2 sites
- Active, not recruiting
Hospital Universitari Vall d'Hebron
Barcelona
- Active, not recruiting
Hospital Clinico San Carlos
Madrid
Poland1 site, 1 recruiting
- Recruiting
Jagiellonia University
Krakow
Jaroslaw B. Garlicki, Dr.
Jaroslaw B. Garlicki, Dr.
United Kingdom1 site, 1 recruiting
- Recruiting
Royal Surrey NHS Foundation Trust
London
Lui Forni, Prof.
Lui Forni, Prof.
About this study
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
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
Read the 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.
- Conditions
- Bloodstream Infection
- Being tested
- Seraph 100,The Microbind Affinity Blood Filter
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seraph 100,The Microbind Affinity Blood FilterDevice
Treatment with Seraph 100 in one arm
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Other | Treatment with Seraph Filter Receives: Device: Seraph 100,The Microbind Affinity Blood Filter |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of pathogens load
Reduction of pathogens load from the bloodstream during treatment
Measured: 4,5 hours +/- 30 min
Secondary outcomes (7)
All-cause mortality
All-cause mortality
Measured: 90 days
Persistence/Recurrence of bacteremia
Measure persistence recurrence of bacteremia
Measured: Day 1, day 2, day 7
Persistence/Recurrence of sepsis
Measure persistence recurrence of sepsis
Measured: Daily during ICU stay or at least day 1, day 2, day 7
Organ dysfunction-free days
Measure organ dysfunction free days
Measured: Daily during ICU stay or at least day 1, day 2, day 7
Change of Intensive Care Unit (ICU) complications
Reduction of ICU complications
Measured: Daily during ICU stay or at least day 1, day 2, day 7
Ventilator-free days (VFDs)
VFD
Measured: Daily during ICU stay or at least day 1, day 2, day 7
Length of stay (LOS) at ICU and hospital ward
Measure LOS
Measured: During ICU and hospital ward stay or at least day 1, day 2, day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2020
- Study start19 Aug 2020
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bloodstream InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open randomized post-market trial
- Masking
- None (open label)
- Enrolment
- 232 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ExThera Medical Europe BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ExThera Medical Corporation, Vivantes Clinic Neukölln
- Responsible party
- Sponsor
- Investigators
- Herwig Gerlach, Prof., Principal investigator, Vivantes Clinic Neukölln
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04260789
- Sponsor's protocol ID
- CP015
- Status last verified
- Dec 2021
- First submitted
- 5 Feb 2020
- Last updated
- 17 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04260789
- Acronym / sponsor ID
- CP015
- Conditions
- Bloodstream Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 232 participants (estimated)
- Lead sponsor
- ExThera Medical Europe BVIndustry (pharma, biotech, devices)
- Collaborators
- ExThera Medical Corporation, Vivantes Clinic Neukölln
- Study start
- 19 Aug 2020 (actual)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 7 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open randomized post-market trial
| Arm | Type | Receives |
|---|---|---|
| Treatment | Other | Device: Seraph 100,The Microbind Affinity Blood FilterTreatment with Seraph Filter |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Seraph 100,The Microbind Affinity Blood FilterTreatment with Seraph 100 in one arm | Device | Treatment |
Primary outcome
Reduction of pathogens load
Time frame: 4,5 hours +/- 30 min
Reduction of pathogens load from the bloodstream during treatment
7 secondary outcomes
All-cause mortality
Time frame: 90 days
Persistence/Recurrence of bacteremia
Time frame: Day 1, day 2, day 7
Persistence/Recurrence of sepsis
Time frame: Daily during ICU stay or at least day 1, day 2, day 7
Organ dysfunction-free days
Time frame: Daily during ICU stay or at least day 1, day 2, day 7
Change of Intensive Care Unit (ICU) complications
Time frame: Daily during ICU stay or at least day 1, day 2, day 7
Ventilator-free days (VFDs)
Time frame: Daily during ICU stay or at least day 1, day 2, day 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2021.
Related trials for Bloodstream Infection
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Herwig Gerlach, Prof. principal investigator
Vivantes Clinic Neukölln
25 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Seraph 100,The Microbind Affinity Blood Filter in people with Bloodstream Infection, run by ExThera Medical Europe BV at 25 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 25 sites in Germany, France, Italy, Belgium, Netherlands and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Carla Kikken-Jussen (+31438200399, carla@extheramedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of pathogens load (time frame: 4,5 hours +/- 30 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2021.