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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00791310 |
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Date of registration:
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13/11/2008 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Evaluation of MorphoTEP With the FDG Among Patients in Severe Sepsis of Unspecified Etiology
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Scientific title:
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Phase 3b,Evaluation of MorphoTEP With the FDG Among Patients in Severe Sepsis of Unspecified Etiology |
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Date of first enrolment:
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November 2008 |
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Target sample size:
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30 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00791310 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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France
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Contacts
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Name:
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sebastien Gibot, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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CHU Nancy |
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Name:
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sebastien md gibot, PhD |
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Address:
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Telephone:
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+33 3 83 85 29 70 |
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Email:
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s.gibot@chu-nancy.fr |
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Affiliation:
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Name:
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sebastien GIBOT, MD, PhD |
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Address:
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Telephone:
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+33 3 83 85 29 70 |
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Email:
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s.gibot@chu-nancy.fr |
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Affiliation:
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
80 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Severe Sepsis
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Intervention(s)
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Drug: Flucis
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Primary Outcome(s)
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Percentage of TEP exams useful for the diagnosis and/or with therapeutic implications.
[Time Frame: 28 days]
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Secondary Outcome(s)
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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]
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Reproducibility of the interpretations carried out under the conditions of protocol
[Time Frame: 28 days]
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Frequency of the medical and technical complications associated with the procedure
[Time Frame: 28 days]
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Secondary ID(s)
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2008-A00780-55
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V1 01/03/2008
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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