- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00709358
Diagnosis of Septicaemia by Detection of Microbial DNA in Blood in Severe Infections (EVAMICA)
Health Economic Evaluation of Rapid Detection of Bacteraemia and Fungemia by Real Time PCR for Cases of Febrile Neutropenia, Suspicion of Endocarditis and Severe Sepsis in Intensive Care Units
The primary purpose is to improve and quicken the microbial diagnosis in severe infections, since only one third of the cases are documented by blood cultures and adequate anti-infective therapy in the 48 hours reduced mortality and morbidity.
Our hypothesis is that detection of microbial DNA in blood by real time PCR may increase the number of cases diagnosed for bacteraemia or fungemia and shorten the time to positive results, which will provide information for an adequate anti-infectious therapy.
Study Overview
Status
Conditions
Detailed Description
We will evaluate the advantage of adding the molecular test to the microbial investigations usually done (blood cultures and others) in cases of febrile neutropenia, suspicion of infective endocarditis and severe sepsis in intensive care units.
This is a prospective study conducted in 18 sites (7 in the Paris area and 11 all over France) which will enrolled about 2000 patients over 18 years. Sites are randomized for starting with a 6-month period performing the test or 6-month period without the test (control time with the standard of care).
Primary outcome are the number of patients with documented bacteraemia or fungemia. Secondary outcome are (1) the number of patients with an adequate anti-infective therapy and how long it happens after the diagnosis, (2) mortality, (3) new complicated infection, (4) number of investigations (microbial and non microbial) done for the etiological diagnosis, and global hospitalization costs.
The advantage of the new test will be evaluated per protocol and with an intend to treat analyses. We hypothesized that the new test will bring 15% more microbial diagnosis than the standard of care. Consequently, and according to the number of sites interested in the study, 166 to 2500 patients will be enrolled with 480 to 750 patients with febrile neutropenia, 1000 to 1500 patients with severe sepsis in Intensive Care Units (ICU). Patients with suspicion of infective endocarditis will be evaluated for the number of diagnosis of true endocarditis according to Duke Criteria, and the time to diagnosis.
Health economic evaluation will compare the costs of hospitalization, microbial investigations including the new test, other non clinical investigations and consequences on the organization.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
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-
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Créteil, France
- CHU Henri Mondor
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age≥ 18 years
- Written signed and dated inform consent
- First time with fever observed in a neutropenic patient
- Severe sepsis in a patient hospitalized in ICU
- Suspicion of infective endocarditis
- Microbial investigation from Monday to Friday
Exclusion Criteria:
- Not affiliated to Health Insurance (social security)
- Included in another interventional trial testing microbial DNA detection during the time "without Septifast®"
- Included in another clinical trial for which the clinician assumes that it will not be possible to prescribe an anti-infectious therapy adequately to microbial detection in the blood
- Patient previously included in the protocol
- Sepsis with a microbial diagnosis
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 2
Detection by blood culture
|
A blood culture is a test to find an infection in the blood.
Most bacteria can be seen in the culture in 2 to 3 days, but some types can take 10 days or longer to show up.
Fungus can take up to 30 days to show up in the culture.
|
Experimental: 1
Test LightCycler SeptiFast® (Roche)
|
The LightCycler® SeptiFast Test, the innovative real-time PCR test from Roche Diagnostics, is designed to detect and identify the 25 most important bacterial and fungal species causing bloodstream infections within just a few hours. The LightCycler® SeptiFast Test detects the pathogenic bacteria and fungi directly from whole blood without the need for prior incubation or culture steps. Rapid detection and identification of bacterial and fungal DNA, directly from a 1.5 ml whole blood sample, without prior incubation or culture steps in less than 6 hours. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of bacteraemia and of fungemia - overall - each condition
Time Frame: max Day 30
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max Day 30
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of patients with adequate anti-infective therapy
Time Frame: at day 30
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at day 30
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Adequate anti-infective therapy
Time Frame: at 24h, 48h, > 48h
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at 24h, 48h, > 48h
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Time between sampling for microbial investigation and positive results relevant for the diagnosis
Time Frame: between sampling for microbial investigation and positive results
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between sampling for microbial investigation and positive results
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Mortality
Time Frame: at Day 30
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at Day 30
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Sepsis chock, secondary infectious focus
Time Frame: at Day 30
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at Day 30
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For neutropenia cases, number of patients who evaluated with a clinical focus of infection
Time Frame: at day 30
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at day 30
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Diagnosis of endocarditis
Time Frame: at Day 45
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at Day 45
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Number of non clinical investigations (microbial and non microbial)
Time Frame: at day 30
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at day 30
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Length of hospital stay
Time Frame: at day 30
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at day 30
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Emmanuelle CAMBAU, PH, Assistance Publique - Hôpitaux de Paris
- Principal Investigator: René COURCOL, PH, CHRU Lille
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Infections
- Systemic Inflammatory Response Syndrome
- Inflammation
- Wounds and Injuries
- Hematologic Diseases
- Agranulocytosis
- Leukopenia
- Leukocyte Disorders
- Body Temperature Changes
- Heat Stress Disorders
- Sepsis
- Neutropenia
- Hyperthermia
- Fever
- Endocarditis
- Febrile Neutropenia
Other Study ID Numbers
- P070308
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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