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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phase 3b,Evaluation of MorphoTEP With the FDG Among Patients in Severe Sepsis of Unspecified Etiology

Conditions
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Severe Sepsis

Intervention / Treatment
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* Drug: Flucis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TEP<br>Performance of of TEP coupled to scanner X | Drug: Flucis<br>* FDG injected i.v<br>* Other names: FDG;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of TEP exams useful for the diagnosis and/or with therapeutic implications. |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 28 days | 
| Reproducibility of the interpretations carried out under the conditions of protocol |  | 28 days | 
| Frequency of the medical and technical complications associated with the procedure |  | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Medical ICU, Severe sepsis