Severe SepsisPhase 3NCT00791310
Evaluation of MorphoTEP With the FDG Among Patients in Severe Sepsis of Unspecified Etiology
A Phase 3 study testing Flucis in people with Severe Sepsis, run by Central Hospital, Nancy, France at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Severe Sepsis
- What is being tested?
- Flucis
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2008to Oct 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU; Central Hospital
Nancy, 54000
sebastien md gibot, PhD, +33 3 83 85 29 70, s.gibot@chu-nancy.fr
About this study
Official title: Phase 3b,Evaluation of MorphoTEP With the FDG Among Patients in Severe Sepsis of Unspecified Etiology
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.
Read the 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.
- Conditions
- Severe Sepsis
- Being tested
- Flucis
- Keywords
- Medical ICU, Severe sepsis
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlucisDrug
Also called FDG
FDG injected i.v
| Study group | Role | What they receive |
|---|---|---|
| TEP | Experimental | Performance of of TEP coupled to scanner X Receives: Drug: Flucis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of TEP exams useful for the diagnosis and/or with therapeutic implications.
Measured: 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
Measured: 28 days
Reproducibility of the interpretations carried out under the conditions of protocol
Measured: 28 days
Frequency of the medical and technical complications associated with the procedure
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionOct 2010 (estimated)
- Study completionOct 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe SepsisStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Investigators
- sebastien Gibot, MD, PhD, Principal investigator, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00791310
- Sponsor's protocol ID
- V1 01/03/2008
- Other IDs
- 2008-A00780-55
- Status last verified
- Dec 2010
- First submitted
- 13 Nov 2008
- Last updated
- 31 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3b,Evaluation of MorphoTEP With the FDG Among Patients in Severe Sepsis of Unspecified Etiology
- ClinicalTrials.gov ID
- NCT00791310
- Acronym / sponsor ID
- V1 01/03/2008
- Conditions
- Severe Sepsis
- Keywords
- Medical ICU, Severe sepsis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Oct 2010 (estimated)
- Study completion
- Oct 2010 (estimated)
- First posted
- 14 Nov 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TEP | Experimental | Drug: FlucisPerformance of of TEP coupled to scanner X |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FlucisAlso: FDGFDG injected i.v | Drug | TEP |
Primary outcome
Percentage of TEP exams useful for the diagnosis and/or with therapeutic implications.
Time frame: 28 days
3 secondary outcomes
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
Reproducibility of the interpretations carried out under the conditions of protocol
Time frame: 28 days
Frequency of the medical and technical complications associated with the procedure
Time frame: 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
sebastien Gibot, MD, PhD principal investigator
Central Hospital, Nancy, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Flucis in people with Severe Sepsis, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact sebastien GIBOT, MD, PhD (+33 3 83 85 29 70, s.gibot@chu-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of TEP exams useful for the diagnosis and/or with therapeutic implications. (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2010; AzTrials last refreshed its copy on 7 Nov 2026.