Evaluation of MorphoTEP With the FDG Among Patients in Severe Sepsis of Unspecified Etiology
Recruitment status was Recruiting
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.
|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|
- Percentage of TEP exams useful for the diagnosis and/or with therapeutic implications. [ Time Frame: 28 days ] [ Designated as safety issue: No ]
- 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 ]
|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)|
Performance of of TEP coupled to scanner X
FDG injected i.v
Other Name: FDG
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00791310
|Contact: sebastien GIBOT, MD, PhD||+33 3 83 85 29 firstname.lastname@example.org|
|CHU; Central Hospital||Recruiting|
|Nancy, France, 54000|
|Contact: sebastien md gibot, PhD +33 3 83 85 29 70 email@example.com|
|Principal Investigator:||sebastien Gibot, MD, PhD||CHU Nancy|