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

Primary Purpose

Severe Sepsis

Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Flucis
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Sepsis focused on measuring Medical ICU, Severe sepsis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU; Central HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TEP

Arm Description

Performance of of TEP coupled to scanner X

Outcomes

Primary Outcome Measures

Percentage of TEP exams useful for the diagnosis and/or with therapeutic implications.

Secondary Outcome Measures

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
Reproducibility of the interpretations carried out under the conditions of protocol
Frequency of the medical and technical complications associated with the procedure

Full Information

First Posted
November 13, 2008
Last Updated
December 30, 2010
Sponsor
Central Hospital, Nancy, France
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1. Study Identification

Unique Protocol Identification Number
NCT00791310
Brief Title
Evaluation of MorphoTEP With the FDG Among Patients in Severe Sepsis of Unspecified Etiology
Official Title
Phase 3b,Evaluation of MorphoTEP With the FDG Among Patients in Severe Sepsis of Unspecified Etiology
Study Type
Interventional

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Unknown status
Study Start Date
November 2008 (undefined)
Primary Completion Date
October 2010 (Anticipated)
Study Completion Date
October 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Central Hospital, Nancy, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Sepsis
Keywords
Medical ICU, Severe sepsis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TEP
Arm Type
Experimental
Arm Description
Performance of of TEP coupled to scanner X
Intervention Type
Drug
Intervention Name(s)
Flucis
Other Intervention Name(s)
FDG
Intervention Description
FDG injected i.v
Primary Outcome Measure Information:
Title
Percentage of TEP exams useful for the diagnosis and/or with therapeutic implications.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
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
Title
Reproducibility of the interpretations carried out under the conditions of protocol
Time Frame
28 days
Title
Frequency of the medical and technical complications associated with the procedure
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
sebastien GIBOT, MD, PhD
Phone
+33 3 83 85 29 70
Email
s.gibot@chu-nancy.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
sebastien Gibot, MD, PhD
Organizational Affiliation
CHU Nancy
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU; Central Hospital
City
Nancy
ZIP/Postal Code
54000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
sebastien md gibot, PhD
Phone
+33 3 83 85 29 70
Email
s.gibot@chu-nancy.fr

12. IPD Sharing Statement

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

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