Septic ShockFc-MBL/PAMPsNCT03457038
Use of Fc-MBL to Detect and Monitor the Presence of PAMPs During Septic Shock
A study testing Blood Test in people with Septic Shock, run by University Hospital, Toulouse at 1 site in France.
Trial summary
Use Mannose Binding Lectin (MBL) as a biomarker to measure levels of Pathogen- Associated Molecular Patterns (PAMP) during septic shock. This will allow evaluating interest of this biomarker to monitor and manage a septic shock. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- What is being tested?
- Blood Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 18 Oct 2018to 18 Jul 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients
- Hospitalized in Intensive Care Unit for sepsis of any etiology
- Patients with shock criteria: defined by a hypotension, hyperlactatemia, the use of vasopressive drugs.
- Patient affiliated to a social security scheme- Patient giving consent
Who cannot join
- Minor patients
- Organ transplant
- Immunosuppressive drugs, other than corticosteroids
- Patients who decline participating to the assay
- Persons placed under legal protection, guardianship
- Pregnant woman
- Subject participating in another search including a exclusion period still in progress at pre-inclusion
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
University Hospital Toulouse
Toulouse, 31059
Eric Oswald, MD, 5 67 69 04 17 ext. 33, oswald.e@chu-toulouse.fr
Isabelle Olivier, PhD, 5 61 77 70 51 ext. 33, olivier.i@chu-toulouse.fr
About this study
Official title: Use of Fc Mannose-Binding Lectin to Detect and Monitor the Presence of Pathogen-Associated Molecular Patterns During Septic Shock
Use Mannose Binding Lectin (MBL) as a biomarker to measure levels of Pathogen- Associated Molecular Patterns (PAMP) during septic shock. This will allow evaluating interest of this biomarker to monitor and manage a septic shock. Consecutive patients admitted for sepsis in Intensive Care Unit Department will be included. This biomarker will be compared to all the parameters monitored usually for these patients in standard care.
Read the detailed description
Septic shock still represent a major cause of admission in intensive care unit, incidence of severe sepsis is increasing, even in western countries, due to aging populations and comorbidities. Definition of septic shock was revised in 2016 by a task force, which emphasizes the need for future iterations. Indeed, there are no simple clinical or biological criteria ton diagnose septic patients with high risk of shock, or to prognose its severity. C-reactive protein (CRP) and procalcitonin (PCT) are the wider biomarkers used to monitor septic patients. But they do not correlate with sepsis severity and moreover do not distinguish unequivocally between infection and noninfected systemic inflammatory response syndrome (SIRS). Each microorganism has number of PAMPs, cell wall components (lipopolysaccharide endotoxin, peptidoglycan, outer membrane vesicles), flagella, mannan… High levels of these pathogen fragments are released in the bloodstream during sepsis. They trigger release of inflammatory cytokines that drive the sepsis cascade. Mannose binding lectin plays a pivotal role in innate immunity, binding with surface sugars of wide range of pathogens and their fragments. Thus MBL promotes opsonophagocytosis and activates the lectin-complement pathway. Fc-MBL, an engineered version of MBL has been developed to capture microorganism and treat sepsis. An ELISA, using Fc-MBL was developed to measure PAMPs in whole blood during sepsis. This assay will use Fc-MBL ELISA to quantify PAMPs during septic shock, to improve diagnostic and monitoring. But also, identifying patients with high levels of PAMPs for dialysis-like sepsis therapies.
PAMP's level will be compared to clinical, biological, microbiological and therapeutic outcomes. Its sensitivity will be evaluated by its kinetic among a septic shock (defined with Sepsis-3 criteria) and by correlation with CRP (C-Reactive Protein) and PCT (Procalcitonin). Its specificity will be evaluated by comparing its levels during septic and non-septic shocks.
- Conditions
- Septic Shock
- Being tested
- Blood Test
- Keywords
- Mannose-Binding Lectin, PAMPs,
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood TestBiological
Addition to the current care but during the normal follow-up visit :
- At the entrance to the service: search for bacterial 16S RNA in the blood
- Additional blood tests (4) at T6-12-18 and 36h
- At each visit: Sampling of an additional heparinized blood tube for the assay PAMPs.
- 1 time per day: Assay of CRP and PCT from samples taken in common practice
- J30: Assessment of the vital status of the patient
| Study group | Role | What they receive |
|---|---|---|
| Patient with Septic Shock | Experimental | Patient Hospitalized in Intensive Care Unit for sepsis of any etiology. The number of follow-up visits will not be changed compared to usual patient follow-up hospitalized in the intensive care unit but there will be blood testing more frequently Receives: Biological: Blood Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantify in whole blood presence of PAMP during a septic shock,
Quantify in whole blood presence of PAMP during a septic shock, using Fc-MBL ELISA :t o improve diagnostic by distinguishing a septic shock from another shock, and stating prognosis by studying PAMP kinetic under antibiotherapy.
Measured: Follow-up during 30 days
Secondary outcomes (3)
Compare accuracy of Fc-MBL ELISA PAMP assay to CRP and PCT during septic shock.
PAMP's level will be compared to clinical, biological, microbiological and therapeutic outcomes. Its sensitivity will be evaluated by its kinetic among a septic shock (defined with Sepsis-3 criteria) and by correlation with CRP and PCT. Its specificity will be evaluated by comparing its levels during septic and non-septic shocks.
Measured: Follow-up during 30 days
Study PAMP's kinetic during septic shock from various origins
PAMP's level will be compared to clinical, biological, microbiological and therapeutic outcomes. Its sensitivity will be evaluated by its kinetic among a septic shock (defined with Sepsis-3 criteria) and by correlation with CRP and PCT. Its specificity will be evaluated by comparing its levels during septic and non-septic shocks.
Measured: Follow-up during 30 days
Identify patients who could beneficiate to a dialysis-like therapy
identifying patients with high levels of PAMPs for dialysis-like sepsis therapies
Measured: Follow-up during 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2018
- Study start18 Oct 2018
- Primary completion18 Jul 2019 (estimated)
- Study completion18 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Major patients admitted to the Resuscitation Department of the CHU Toulouse-Rangueil for severe sepsis, or development of sepsis during the stay resuscitation; sepsis defined by a SOFA score ≥ 2
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard Medical School (HMS and HSDM)
- Responsible party
- Sponsor
- Investigators
- Eric Oswald, MD, Principal investigator, University Hospital, Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03457038
- Sponsor's protocol ID
- RC31/17/0157
- Other IDs
- 2017-A01686-47
- Acronym
- Fc-MBL/PAMPs
- Status last verified
- Apr 2019
- First submitted
- 26 Feb 2018
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bicart-See A, Vardon F, Ruiz S, Conil JM, Tudal V, Super M, Ingber DE, Oswald E. Kinetics of molecular patterns captured by mannose-binding lectin in septic shock correlate with clinical outcome: a monocentric prospective observational study. Intensive Care Med Exp. 2025 Dec 10;13(1):123. doi: 10.1186/s40635-025-00832-x.
PubMed 41366523
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Fc Mannose-Binding Lectin to Detect and Monitor the Presence of Pathogen-Associated Molecular Patterns During Septic Shock
- ClinicalTrials.gov ID
- NCT03457038
- Acronym / sponsor ID
- Fc-MBL/PAMPs / RC31/17/0157
- Conditions
- Septic Shock
- Keywords
- Mannose-Binding Lectin, PAMPs,
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Collaborators
- Harvard Medical School (HMS and HSDM)
- Study start
- 18 Oct 2018 (actual)
- Primary completion
- 18 Jul 2019 (estimated)
- Study completion
- 18 Jul 2019 (estimated)
- First posted
- 7 Mar 2018 (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.
Use Mannose Binding Lectin (MBL) as a biomarker to measure levels of Pathogen- Associated Molecular Patterns (PAMP) during septic shock. This will allow evaluating interest of this biomarker to monitor and manage a septic shock. Consecutive patients admitted for sepsis in Intensive Care Unit Department will be included. This biomarker will be compared to all the parameters monitored usually for these patients in standard care.
Detailed description
Septic shock still represent a major cause of admission in intensive care unit, incidence of severe sepsis is increasing, even in western countries, due to aging populations and comorbidities. Definition of septic shock was revised in 2016 by a task force, which emphasizes the need for future iterations. Indeed, there are no simple clinical or biological criteria ton diagnose septic patients with high risk of shock, or to prognose its severity. C-reactive protein (CRP) and procalcitonin (PCT) are the wider biomarkers used to monitor septic patients. But they do not correlate with sepsis severity and moreover do not distinguish unequivocally between infection and noninfected systemic inflammatory response syndrome (SIRS). Each microorganism has number of PAMPs, cell wall components (lipopolysaccharide endotoxin, peptidoglycan, outer membrane vesicles), flagella, mannan… High levels of these pathogen fragments are released in the bloodstream during sepsis. They trigger release of inflammatory cytokines that drive the sepsis cascade. Mannose binding lectin plays a pivotal role in innate immunity, binding with surface sugars of wide range of pathogens and their fragments. Thus MBL promotes opsonophagocytosis and activates the lectin-complement pathway. Fc-MBL, an engineered version of MBL has been developed to capture microorganism and treat sepsis. An ELISA, using Fc-MBL was developed to measure PAMPs in whole blood during sepsis. This assay will use Fc-MBL ELISA to quantify PAMPs during septic shock, to improve diagnostic and monitoring. But also, identifying patients with high levels of PAMPs for dialysis-like sepsis therapies.
PAMP's level will be compared to clinical, biological, microbiological and therapeutic outcomes. Its sensitivity will be evaluated by its kinetic among a septic shock (defined with Sepsis-3 criteria) and by correlation with CRP (C-Reactive Protein) and PCT (Procalcitonin). Its specificity will be evaluated by comparing its levels during septic and non-septic shocks.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Major patients admitted to the Resuscitation Department of the CHU Toulouse-Rangueil for severe sepsis, or development of sepsis during the stay resuscitation; sepsis defined by a SOFA score ≥ 2
| Arm | Type | Receives |
|---|---|---|
| Patient with Septic Shock | Experimental | Biological: Blood TestPatient Hospitalized in Intensive Care Unit for sepsis of any etiology. The number of follow-up visits will not be changed compared to usual patient follow-up hospitalized in the intensive care unit but there will be blood testing more frequently |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients
- Hospitalized in Intensive Care Unit for sepsis of any etiology
- Patients with shock criteria: defined by a hypotension, hyperlactatemia, the use of vasopressive drugs.
- Patient affiliated to a social security scheme- Patient giving consent
Key exclusion criteria (7 listed)
- Minor patients
- Organ transplant
- Immunosuppressive drugs, other than corticosteroids
- Patients who decline participating to the assay
- Persons placed under legal protection, guardianship
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 |
|---|---|---|
| Blood TestAddition to the current care but during the normal follow-up visit : * At the entrance to the service: search for bacterial 16S RNA in the blood * Additional blood tests (4) at T6-12-18 and 36h * At each visit: Sampling of an additional heparinized blood tube for the assay PAMPs. * 1 time per day: Assay of CRP and PCT from samples taken in common practice * J30: Assessment of the vital status of the patient | Biological | Patient with Septic Shock |
Primary outcome
Quantify in whole blood presence of PAMP during a septic shock,
Time frame: Follow-up during 30 days
Quantify in whole blood presence of PAMP during a septic shock, using Fc-MBL ELISA :t o improve diagnostic by distinguishing a septic shock from another shock, and stating prognosis by studying PAMP kinetic under antibiotherapy.
3 secondary outcomes
Compare accuracy of Fc-MBL ELISA PAMP assay to CRP and PCT during septic shock.
Time frame: Follow-up during 30 days
Study PAMP's kinetic during septic shock from various origins
Time frame: Follow-up during 30 days
Identify patients who could beneficiate to a dialysis-like therapy
Time frame: Follow-up during 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
- Derived from this study: PubMed 41366523Bicart-See A, Vardon F, Ruiz S, Conil JM, Tudal V, Super M, Ingber DE, Oswald E. Kinetics of molecular patterns captured by mannose-binding lectin in septic shock correlate with clinical outcome: a monocentric prospective observational study. Intensive Care Med Exp. 2025 Dec 10;13(1):123. doi: 10.1186/s40635-025-00832-x.
- Individual participant dataSharing planned: No
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Sepsis
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.
Eric Oswald, MD principal investigator
University Hospital, Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Test in people with Septic Shock, run by University Hospital, Toulouse at 1 site in France.
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 4 inclusion and 7 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 18 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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 Eric Oswald, MD (5 67 69 04 17 ext. 33, oswald.e@chu-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantify in whole blood presence of PAMP during a septic shock, (time frame: Follow-up during 30 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 NCT03457038, 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 18 Apr 2019.