Use of Fc-MBL to Detect and Monitor the Presence of PAMPs During Septic Shock

NCT03457038 | Unknown

• 2 other identifiers: RC31/17/01572017-A01686-47
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Septic Shock

Keywords

Mannose-Binding Lectin, PAMPs,

Outcome Measures

Primary Outcomes (1)

• 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.

  Follow-up during 30 days

Secondary Outcomes (3)

• Compare accuracy of Fc-MBL ELISA PAMP assay to CRP and PCT during septic shock.

  Follow-up during 30 days

• Study PAMP's kinetic during septic shock from various origins

  Follow-up during 30 days

• Identify patients who could beneficiate to a dialysis-like therapy

  Follow-up during 30 days

Study Arms (1)

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

Biological: Blood Test

Interventions

Blood Test BIOLOGICAL

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

Patient with Septic Shock

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Minor patients
• Organ transplant
• Immunosuppressive drugs, other than corticosteroids
• Patients who decline participating to the assay
• Persons placed under legal protection, guardianship
• Pregnant woman

Sponsors & Collaborators

• University Hospital, Toulouse: lead
• Harvard Medical School (HMS and HSDM): collaborator

Study Sites (1)

University Hospital Toulouse

Toulouse, 31059, France

RECRUITING

Related Publications (1)

• 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.

  PMID: 41366523 DERIVED

MeSH Terms

Conditions

Shock, Septic

Interventions

Hematologic Tests

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Eric Oswald, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric Oswald, MD

CONTACT

5 67 69 04 17; oswald.e@chu-toulouse.fr

Isabelle OLIVIER, PhD

CONTACT

5 61 77 70 51; olivier.i@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: February 26, 2018
• First Posted: March 7, 2018
• Study Start: October 18, 2018
• Primary Completion: July 18, 2019
• Study Completion: July 18, 2019
• Last Updated: April 18, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)