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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00791310
Recruitment Status : Unknown
Verified December 2010 by Central Hospital, Nancy, France.
Recruitment status was:  Recruiting
First Posted : November 14, 2008
Last Update Posted : December 31, 2010
Information provided by:
Central Hospital, Nancy, France

November 13, 2008
November 14, 2008
December 31, 2010
November 2008
October 2010   (Final data collection date for primary outcome measure)
Percentage of TEP exams useful for the diagnosis and/or with therapeutic implications. [ Time Frame: 28 days ]
Same as current
Complete list of historical versions of study NCT00791310 on Archive Site
  • 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 ]
  • Reproducibility of the interpretations carried out under the conditions of protocol [ Time Frame: 28 days ]
  • Frequency of the medical and technical complications associated with the procedure [ Time Frame: 28 days ]
Same as current
Not Provided
Not Provided
Evaluation of MorphoTEP With the FDG Among Patients in Severe Sepsis of Unspecified Etiology
Phase 3b,Evaluation of MorphoTEP With the FDG Among Patients in Severe Sepsis of Unspecified Etiology
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.

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.

Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Severe Sepsis
Drug: Flucis
FDG injected i.v
Other Name: FDG
Experimental: TEP
Performance of of TEP coupled to scanner X
Intervention: Drug: Flucis
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
October 2010
October 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
V1 01/03/2008
Not Provided
Not Provided
Mr P Boulanger/ Directeur de la Recherche et de l'Innovation, CHU Nancy
Central Hospital, Nancy, France
Not Provided
Principal Investigator: sebastien Gibot, MD, PhD CHU Nancy
Central Hospital, Nancy, France
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP