Evaluation of MorphoTEP With the FDG Among Patients in Severe Sepsis of Unspecified Etiology
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|ClinicalTrials.gov 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
|Condition or disease||Intervention/treatment||Phase|
|Severe Sepsis||Drug: Flucis||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 3b,Evaluation of MorphoTEP With the FDG Among Patients in Severe Sepsis of Unspecified Etiology|
|Study Start Date :||November 2008|
|Estimated Primary Completion Date :||October 2010|
|Estimated Study Completion Date :||October 2010|
Performance of of TEP coupled to scanner X
FDG injected i.v
Other Name: FDG
- Percentage of TEP exams useful for the diagnosis and/or with therapeutic implications. [ Time Frame: 28 days ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00791310
|Contact: sebastien GIBOT, MD, PhD||+33 3 83 85 29 email@example.com|
|CHU; Central Hospital||Recruiting|
|Nancy, France, 54000|
|Contact: sebastien md gibot, PhD +33 3 83 85 29 70 firstname.lastname@example.org|
|Principal Investigator:||sebastien Gibot, MD, PhD||CHU Nancy|