Evaluation of MorphoTEP With the FDG Among Patients in Severe Sepsis of Unspecified Etiology
Phase 3b,Evaluation of MorphoTEP With the FDG Among Patients in Severe Sepsis of Unspecified Etiology
2 other identifiers
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Nov 2008
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2008
CompletedFirst Submitted
Initial submission to the registry
November 13, 2008
CompletedFirst Posted
Study publicly available on registry
November 14, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2010
CompletedDecember 31, 2010
December 1, 2010
1.9 years
November 13, 2008
December 30, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of TEP exams useful for the diagnosis and/or with therapeutic implications.
28 days
Secondary Outcomes (3)
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
Study Arms (1)
TEP
EXPERIMENTALPerformance of of TEP coupled to scanner X
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU; Central Hospital
Nancy, 54000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
sebastien Gibot, MD, PhD
CHU NANCY
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 13, 2008
First Posted
November 14, 2008
Study Start
November 1, 2008
Primary Completion
October 1, 2010
Study Completion
October 1, 2010
Last Updated
December 31, 2010
Record last verified: 2010-12