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

November 13, 2008
December 30, 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00791310 on ClinicalTrials.gov 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 ] [ 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 ]
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.

Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
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
Both
18 Years to 80 Years
No
Contact: sebastien GIBOT, MD, PhD +33 3 83 85 29 70 s.gibot@chu-nancy.fr
France
 
NCT00791310
V1 01/03/2008, 2008-A00780-55
No
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