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

Phase 3

• Conditions: Severe Sepsis
• Interventions: Drug: Flucis

• Registration Number: NCT00791310
• Lead Sponsor: Central Hospital, Nancy, France

Brief Summary

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

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 Timeline

• Study Start: 2008-11
• Study First Submitted: 2008-11-13
• Study First Submitted QC: 2008-11-13
• Study First Posted: 2008-11-14
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-30
• Last Update Posted: 2010-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TEP	Flucis	Performance of of TEP coupled to scanner X

Primary Outcome Measures

Name	Time	Method
Percentage of TEP exams useful for the diagnosis and/or with therapeutic implications.	28 days

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

CHU; Central Hospital; 🇫🇷 Nancy, France