SIRS and Bacterial Sepsis Discrimination by Biomarkers in ICU (Captain)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2011 by Groupe Hospitalier Paris Saint Joseph.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Biomerieux
Institut Pasteur
Assistance Publique - Hôpitaux de Paris
Information provided by (Responsible Party):
Groupe Hospitalier Paris Saint Joseph
ClinicalTrials.gov Identifier:
NCT01378169
First received: May 9, 2011
Last updated: October 7, 2011
Last verified: October 2011
  Purpose

Aim of the study : The primary aim of the investigators study is to highlight the presence of biomarkers (biological indicators of the presence of inflammation or infection) of infectious processes during the systemic inflammatory response (SIRS) allowing, first to discriminate non-infectious inflammation from infectious processes and secondary to determine the microbial pathogen responsive of the infection. For this purpose the investigators will conduct a combinatorial approach of several blood markers including usual markers of inflammation and other blood and cells markers. Expression of small pieces of RNA (miRNA) known to inhibit determined gene expression, will also be analysed in monocytes (a specific group of white blood cells involved in the fist line of defences against microbes.

Study design : For this purpose the investigators will include 300 patients admitted to the intensive care unit with suspicion of infection. Serial blood sample will be take for biological parameters analysis. Efficiency of each single parameters and of different combinations of different markers to determine the presence or absence of infection responsive of clinical inflammation will be studied.


Condition
SIRS
Sepsis
Severe Sepsis
Septic Shock

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Early Detection and Diagnostic Performance of Bio-markers During Bacterial Sepsis: Multicentre Cohort Study in Intensive Care

Resource links provided by NLM:


Further study details as provided by Groupe Hospitalier Paris Saint Joseph:

Primary Outcome Measures:
  • Combination of biomarkers in sepsis [ Time Frame: 3 days ( from D0 to D2) ] [ Designated as safety issue: No ]

    The primary endpoint is to determine the ability of each individual parameter and of the different combination to discriminate between sepsis and noninfectious inflammation.

    Each biomarker will be isolatelly studied to determine existence of a cut-off value allowing discrimination between SIRS and sepsis.

    Each positive biomarker (biomarker for which such a cut-off can be determined), will be include in a second study involving all or part of the positive biomarkers to determine the possibility of increasing AUC for discrimination of SIRS and sepsis patients



Secondary Outcome Measures:
  • Pathogen in human fluids (Blood, BAL, CSF, Urin) [ Time Frame: D0 ] [ Designated as safety issue: No ]
    A partnership with Biomerieux laboratory was estabished to allow microbial detection at D0 by a new system of microbial DNA amplification, which is at the moment under development

  • mRNA expression during inflammatory process in white blood cells [ Time Frame: D0 to D3 ] [ Designated as safety issue: No ]
    Study of modification of mRNA expression between SIRS and sepsis during inflammatory process in white blood cells. Study of the expression of whole mRNA in whole blood and of its modification during the 3 fist days of SIRS to determine a potential specific profil during infectious processes


Biospecimen Retention:   Samples Without DNA

blood, urin, CSF, BAL


Estimated Enrollment: 300
Study Start Date: January 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
SIRS patients
Every patient, without exclusion criteria, presenting with SIRS during an hospitalization in ICU.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

ICU patients whatever was their admission indication presenting a SIRS with or without sepsis.

Criteria

Inclusion Criteria:

  • Age> = 18 years
  • Patient hospitalized in ICU with a diagnosis of SIRS:
  • Temperatures above 38 ° C or below 36 ° C

At least one other criterion from:

  • Heart rate> 90 bpm
  • Respiratory rate above 20 breaths / min or PaCO2 <32 mmHg
  • Leukocytosis greater than or less than 4000/mm3 12000/m3

    • Patient admitted in intensive care for less than 12 hours
    • Patient does not preclude its participation in the study.

Exclusion Criteria:

  • Decision to limit treatment before potential inclusion in the study
  • No affiliation to a social security scheme (beneficiary or assignee)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01378169

Locations
France
Groupe hospitalier Paris Saint Joseph Recruiting
Paris, France, 75014
Contact: Benoit Misset, MD    144123415 ext +33    bmisset@hpsj.fr   
Contact: Francois j Philippart, MD PhD    144127021 ext +33    fphilippart@gmail.com   
Principal Investigator: Benoît Misset, MD         
Sub-Investigator: Francois j Philippart, MD; PhD         
Sponsors and Collaborators
Groupe Hospitalier Paris Saint Joseph
Biomerieux
Institut Pasteur
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: François J Philippart, MD; PhD Groupe Hospitalier Paris Saint Joseph
  More Information

Publications:
Responsible Party: Groupe Hospitalier Paris Saint Joseph
ClinicalTrials.gov Identifier: NCT01378169     History of Changes
Other Study ID Numbers: AOM09143, N° 2010-A00908-31
Study First Received: May 9, 2011
Last Updated: October 7, 2011
Health Authority: France: Ministry of Health

Keywords provided by Groupe Hospitalier Paris Saint Joseph:
Sepsis
Severe Sepsis
SIRS
Septic Shock
Inflammatory processes
Cytokines
HLA-DR
HLA type II
Chemokines
TLR expression
mRNA expression in whole blood
Bacterial DNA detection
Prognosis factors
Infection
Diagnosis

Additional relevant MeSH terms:
Sepsis
Toxemia
Shock, Septic
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock

ClinicalTrials.gov processed this record on October 19, 2014