Evaluation of MorphoTEP With the FDG Among Patients in Se... | NCT00791310

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

NCT00791310

Sponsor

Central Hospital, Nancy, France

Status

Unknown status

Last Update Posted

Dec 31, 2010Estimated

Enrollment

30Estimated

Phase

Phase 3

Conditions

Severe Sepsis

Interventions

Flucis

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2008-A00780-55

Status Module

Record Verification Date

Dec 2010

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2008

Primary Completion Date

Oct 2010Estimated

Completion Date

Oct 2010Estimated

First Submitted Date

Nov 13, 2008

First Submission Date that Met QC Criteria

Nov 13, 2008

First Posted Date

Nov 14, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 30, 2010

Last Update Posted Date

Dec 31, 2010Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Central Hospital, Nancy, FranceOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TEP	Experimental	Performance of of TEP coupled to scanner X	Drug: Flucis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Flucis	Drug	FDG injected i.v	TEP	FDG

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
sebastien GIBOT, MD, PhD	Contact	+33 3 83 85 29 70		s.gibot@chu-nancy.fr

Overall Officials

Name	Affiliation	Role
sebastien Gibot, MD, PhD	Central Hospital, Nancy, France	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU; Central Hospital	Recruiting	Nancy		54000	France

Condition Browse Module

MeSH Terms

ID	Term
D018805	Sepsis

Ancestor Terms

ID	Term
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes

Browse Leaves

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Browse Branches

Not provided