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

Severe Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00791310
• Other study ID #: V1 01/03/2008
• Secondary ID: 2008-A00780-55
• Status: Recruiting
• Phase: Phase 3
• First received: November 13, 2008
• Last updated: December 30, 2010
• Start date: November 2008
• Est. completion date: October 2010

Study information

• Verified date: December 2010
• Source: Central Hospital, Nancy, France
• Contact: sebastien GIBOT, MD, PhD
• Phone: +33 3 83 85 29 70
• Email: s.gibot[@]chu-nancy.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sepsis
• Severe Sepsis
• Toxemia

Intervention

Drug:
• Flucis
FDG injected i.v

Locations

Country	Name	City	State
France	CHU; Central Hospital	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of TEP exams useful for the diagnosis and/or with therapeutic implications.		28 days	No
Secondary	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	No
Secondary	Reproducibility of the interpretations carried out under the conditions of protocol		28 days	No
Secondary	Frequency of the medical and technical complications associated with the procedure		28 days	No