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Evaluation of MorphoTEP With the FDG Among Patients in Severe Sepsis of Unspecified Etiology

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Central Hospital, Nancy, France.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Central Hospital, Nancy, France
ClinicalTrials.gov Identifier:
NCT00791310
First received: November 13, 2008
Last updated: December 30, 2010
Last verified: December 2010
History of Changes
  Purpose

The objective of this pilot study is to estimate a procedure where the biological samples routinely obtained at the site of suspected infection could be guided by the early realization of a TEP with FDG coupled to scanner X, in patients hospitalized in ICU for severe sepsis of unspecified etiology.


Condition Intervention Phase
Severe Sepsis
 Drug: Flucis
 Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 3b,Evaluation of MorphoTEP With the FDG Among Patients in Severe Sepsis of Unspecified Etiology

Resource links provided by NLM:

MedlinePlus related topics: Sepsis
U.S. FDA Resources

Further study details as provided by Central Hospital, Nancy, France:

Primary Outcome Measures:
  • Percentage of TEP exams useful for the diagnosis and/or with therapeutic implications. [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of patients for whom local determinations of TREM and sTREM will have made it possible to identify a strong probability of infection of one or more suspected site [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Reproducibility of the interpretations carried out under the conditions of protocol [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • Frequency of the medical and technical complications associated with the procedure [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: November 2008
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: TEP
Performance of of TEP coupled to scanner X
 Drug: Flucis
FDG injected i.v
Other Name: FDG

Detailed Description:

Severe sepsis constitutes the leading cause of mortality in ICU, in particular because a microbial documentation is lacking in about half of the cases.

Tomography by emission of positons, which uses the property of activated macrophages and leucocytes to collect 18F-fluorodeoxyglucose may prove useful to identify the site(s) of infection and then guide sampling.

Thirty patients will be included over 12 months.

Within 24 hours after admission, patients presented with a severe sepsis of still unknown etiology will benefit from the realization of a morphoTEP, including an examination MtOe with the FDG, associated with a conventional scanner X.

Suspected infected sites will then be the subject of sampling when possible. These samples will be send for microbial culture, histology and TREM-1 expression (membrane-bound and soluble form) when appropriate.

The main judgement criteria will be the percentage of the MtOe exams proved to be useful for diagnosis and/or associated with therapeutic modifications.

This pilot study will make it possible to evaluate the interest of the early realization of a TEP/scanner X examination among severe sepsis patients of unknown origin.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient hospitalized with severe sepsis
  • Absence of infected site clearly identified after 48 hours of a conventional diagnosis assessment or suspicion of one or more additional sites
  • Indication of scanner X with injection
  • Informed consent obtained

Exclusion Criteria:

  • Age over 80
  • Immunocompromised status
  • Surgical intervention within the previous month
  • Hemodynamic instability (defined by the use of more than 0.5µg/kg/min vasopressors)
  • Severe hypoxia (defined by a PaO2/FiO2 ratio lower than 150)
  • Pregnancy
  • Patient already included in another protocol
  • Anaphylaxis to Flucis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00791310

Contacts
Contact: sebastien GIBOT, MD, PhD +33 3 83 85 29 70 s.gibot@chu-nancy.fr

Locations
France
CHU; Central Hospital Recruiting
Nancy, France, 54000
Contact: sebastien md gibot, PhD     +33 3 83 85 29 70     s.gibot@chu-nancy.fr    
Sponsors and Collaborators
Central Hospital, Nancy, France
Investigators
Principal Investigator: sebastien Gibot, MD, PhD CHU Nancy
  More Information

No publications provided

Responsible Party: Mr P Boulanger/ Directeur de la Recherche et de l'Innovation, CHU Nancy
ClinicalTrials.gov Identifier: NCT00791310     History of Changes
Other Study ID Numbers: V1 01/03/2008, 2008-A00780-55
Study First Received: November 13, 2008
Last Updated: December 30, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Central Hospital, Nancy, France:
Medical ICU
Severe sepsis

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

ClinicalTrials.gov processed this record on May 23, 2013