BacteremiaNCT02914132
Safety Evaluation of Seraph® 100 to Reduce Bacteremia in Patients on Hemodialysis
A study testing Seraph 100 Filter in people with Bacteremia and Bacterial Infection, run by ExThera Medical Corporation at 4 sites in Germany.
Trial summary
The purpose of this study is to determine whether the Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100) is safe in the treatment of dialysis patients with bacteremia. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Bacteremia, Bacterial Infection
- What is being tested?
- Seraph 100 Filter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 4 sitesGermany
- Study dates
- Feb 2016to 7 Jun 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Require renal replacement therapy.
- Be ≥ 18 years old and ≤ 90 years old
- Positive blood culture and one of the following:
- Clinical evidence of a catheter exit site to tunnel infection as evidenced by redness, tenderness or purulence.
- Bacteremia is proven with two separate blood cultures from independent vein punctures.
- A blood culture with Staphylococcus aureus where the time to positivity is within 14 hours.
- Growth from a blood culture taken from the hemodialysis catheter 2 or more hours before the growth of a blood culture drawn peripherally at the same time.
Who cannot join
- Have an arteriovenous polytetrafluoroethylene (PTFE) graft.
- Lack of a commitment to full aggressive support.
- Have inability to maintain a minimum mean arterial pressure of ≥ 65 mm Hg despite vasopressor therapy and fluid resuscitation.
- Have had chest compressions as part of cardiopulmonary resuscitation (CPR)
- Have had an acute myocardial infarction (MI) within the past 3 months.
- Have had serious injury within 36 hours of screening.
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- Have uncontrolled hemorrhage.
- Are not expected to live > 14 days.
- Have malignancy and are not expected to live 42 days.
- Have neutropenia (absolute neutrophil count <500 cells/µL).
- Have Child-Pugh Class C cirrhosis.
- Have New York Heart Association Class IV Heart Failure or an ejection fraction <30%.
- Have known Antithrombin III deficiency.
- Have platelet count <30,000/µL.
- Cannot have intravenous (IV) supplemental iron halted during trial period.
- Are currently involved in an investigational drug or device trial.
- Have been previously enrolled in this clinical trial.
- Next hemodialysis treatment will not take place for at least 24 hours after enrollment.
- Serious bleedings and clotting disorders, determined by blood transfusion of > 2 units of packed red blood cells, or, An acute (48 h) hemoglobin decline of at least 2 g/dL, transfusion requirement of >4 units over 48h, objective evidence of bleed, documented by physician.
- Breast feeding and pregnant women
- Contraindications for heparin sodium for injection are:
- Have heparin sensitivity
- Severe thrombocytopenia.
- With an uncontrolled active bleeding state, except when this is due to disseminated intravascular coagulation
- In whom suitable blood coagulation tests, e.g. whole blood clotting time, partial thromboplastin time, etc cannot be performed at appropriate intervals (this contraindication refers to full-dose heparin; there is usually no need to monitor coagulation parameters in patients receiving low-dose heparin)
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Klinikum Braunschweig
Braunschweig, 38126
Universitaetsklinikum-Frankfurt
Frankfurt
Medizinische Hochschule-Hannover
Hannover, 30625
Universitatsklinikum Muenster
Münster, 48149
About this study
Official title: Safety and Performance Evaluation of the Seraph® 100 Microbind® Affinity Blood Filter for Reducing Bacteremia in Patients on Hemodialysis
The purpose of this study is to determine whether the Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100) is safe in the treatment of dialysis patients with bacteremia.
Read the detailed description
This trial is a prospective, non-randomized study in patients as an adjunctive treatment for blood stream infection (BSI) in patients on renal replacement therapy. The heparin surface being studied is currently marketed on extracorporeal circuits. It has been shown to absorb various types of Gram positive and Gram negative bacteria and to reduce toxins and cytokines in in vitro studies using whole blood. For this study, patients on renal replacement therapy who develop bacteremia will have the Seraph® 100 Microbind® Affinity Blood Filter included in the dialysis circuit for up to 4 hours, on one day, with hourly monitoring. Patients will be followed for 14 days post treatment. Patients will be monitored by vital signs and laboratory indices on the day of treatment and on post procedure day 1, 2, 3, 4, 5, 6, 7 and 14.
- Conditions
- Bacteremia, Bacterial Infection
- Being tested
- Seraph 100 Filter
- Medical subject headings
- Bacteremia, Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Seraph 100 FilterDevice
Also called Seraph 100
Treatment of renal replacement therapy patients with bacteremia.
| Study group | Role | What they receive |
|---|---|---|
| Seraph 100 Filter | Other | Renal replacement patient with bacteremia. Receives: Device: Seraph 100 Filter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate Safety of the ExThera Medical Seraph® 100 Microbind® Affinity Blood Filter in a Hemodialysis Circuit Assessed by Rate of Adverse Events.
Demonstrate safety of the ExThera Medical Seraph® 100 Microbind® Affinity Blood Filter in a hemodialysis circuit assessed by rate of adverse events. No adverse events occured
Measured: 14 days
Secondary outcomes (1)
Reduction of Bacteria in Blood Passed Through the Seraph 100 Filter.
Pathogen reduction of > 40 % as CFU/mL or an increase in time to positivity (TTP) of > 22 minutes in blood passed through the Seraph 100 Filter
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2016 (estimated)
- Study startFeb 2016
- Primary completion7 Jun 2018
- Study completion7 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BacteremiaStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- ExThera Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jan T Kielstein, MD,FASN,FERA, Principal investigator, Academic Teaching Hospital Braunschweig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02914132
- Sponsor's protocol ID
- CP001
- Status last verified
- Jan 2018
- First submitted
- 22 Sep 2016
- Last updated
- 12 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Eden G, Schmidt JJ, Buttner S, Kumpers P, Hafer C, Rovas A, Koch BF, Schmidt BMW, Kielstein JT. Safety and efficacy of the Seraph(R) 100 Microbind(R) Affinity Blood Filter to remove bacteria from the blood stream: results of the first in human study. Crit Care. 2022 Jun 17;26(1):181. doi: 10.1186/s13054-022-04044-7.
PubMed 35715801
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Performance Evaluation of the Seraph® 100 Microbind® Affinity Blood Filter for Reducing Bacteremia in Patients on Hemodialysis
- ClinicalTrials.gov ID
- NCT02914132
- Acronym / sponsor ID
- CP001
- Conditions
- Bacteremia, Bacterial Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- ExThera Medical CorporationIndustry (pharma, biotech, devices)
- Study start
- Feb 2016
- Primary completion
- 7 Jun 2018 (actual)
- Study completion
- 7 Jun 2018 (actual)
- First posted
- 26 Sep 2016 (estimated)
- Results
- Posted 12 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether the Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100) is safe in the treatment of dialysis patients with bacteremia.
Detailed description
This trial is a prospective, non-randomized study in patients as an adjunctive treatment for blood stream infection (BSI) in patients on renal replacement therapy. The heparin surface being studied is currently marketed on extracorporeal circuits. It has been shown to absorb various types of Gram positive and Gram negative bacteria and to reduce toxins and cytokines in in vitro studies using whole blood. For this study, patients on renal replacement therapy who develop bacteremia will have the Seraph® 100 Microbind® Affinity Blood Filter included in the dialysis circuit for up to 4 hours, on one day, with hourly monitoring. Patients will be followed for 14 days post treatment. Patients will be monitored by vital signs and laboratory indices on the day of treatment and on post procedure day 1, 2, 3, 4, 5, 6, 7 and 14.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Seraph 100 Filter | Other | Device: Seraph 100 FilterRenal replacement patient with bacteremia. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Require renal replacement therapy.
- Be ≥ 18 years old and ≤ 90 years old
- Positive blood culture and one of the following:
Key exclusion criteria (25 listed)
- Have an arteriovenous polytetrafluoroethylene (PTFE) graft.
- Lack of a commitment to full aggressive support.
- Have inability to maintain a minimum mean arterial pressure of ≥ 65 mm Hg despite vasopressor therapy and fluid resuscitation.
- Have had chest compressions as part of cardiopulmonary resuscitation (CPR)
- Have had an acute myocardial infarction (MI) within the past 3 months.
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 FilterAlso: Seraph 100Treatment of renal replacement therapy patients with bacteremia. | Device | Seraph 100 Filter |
Primary outcome
Demonstrate Safety of the ExThera Medical Seraph® 100 Microbind® Affinity Blood Filter in a Hemodialysis Circuit Assessed by Rate of Adverse Events.
Time frame: 14 days
Demonstrate safety of the ExThera Medical Seraph® 100 Microbind® Affinity Blood Filter in a hemodialysis circuit assessed by rate of adverse events. No adverse events occured
1 secondary outcome
Reduction of Bacteria in Blood Passed Through the Seraph 100 Filter.
Time frame: 4 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35715801Eden G, Schmidt JJ, Buttner S, Kumpers P, Hafer C, Rovas A, Koch BF, Schmidt BMW, Kielstein JT. Safety and efficacy of the Seraph(R) 100 Microbind(R) Affinity Blood Filter to remove bacteria from the blood stream: results of the first in human study. Crit Care. 2022 Jun 17;26(1):181. doi: 10.1186/s13054-022-04044-7.
- Individual participant dataSharing planned: No
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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.
Jan T Kielstein, MD,FASN,FERA principal investigator
Academic Teaching Hospital Braunschweig
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Seraph 100 Filter in people with Bacteremia and Bacterial Infection, run by ExThera Medical Corporation at 4 sites in Germany.
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 7 inclusion and 25 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: finished, as of the sponsor's last update on 12 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany. 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?
Yes. Results are posted in the registry (first posted 12 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demonstrate Safety of the ExThera Medical Seraph® 100 Microbind® Affinity Blood Filter in a Hemodialysis Circuit Assessed by Rate of Adverse Events. (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02914132, which also lists 1 linked publication.
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 12 Aug 2019.