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Diagnosis of Septicaemia by Detection of Microbial DNA in Blood in Severe Infections (EVAMICA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00709358
Recruitment Status : Completed
First Posted : July 3, 2008
Last Update Posted : December 29, 2011
Hoffmann-La Roche
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Febrile Neutropenia Endocarditis Severe Sepsis Other: Detection of microbial DNA in blood by SeptiFast® Other: detection of microbial DNA in blood by blood culture Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: 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
Study Start Date : May 2008
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endocarditis Sepsis

Arm Intervention/treatment
Active Comparator: 2
Detection by blood culture
Other: detection of microbial DNA in blood 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)
Other: Detection of microbial DNA in blood by SeptiFast®

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.

Primary Outcome Measures :
  1. Number of bacteraemia and of fungemia - overall - each condition [ Time Frame: max Day 30 ]

Secondary Outcome Measures :
  1. Number of patients with adequate anti-infective therapy [ Time Frame: at day 30 ]
  2. Adequate anti-infective therapy [ Time Frame: at 24h, 48h, > 48h ]
  3. Time between sampling for microbial investigation and positive results relevant for the diagnosis [ Time Frame: between sampling for microbial investigation and positive results ]
  4. Mortality [ Time Frame: at Day 30 ]
  5. Sepsis chock, secondary infectious focus [ Time Frame: at Day 30 ]
  6. For neutropenia cases, number of patients who evaluated with a clinical focus of infection [ Time Frame: at day 30 ]
  7. Diagnosis of endocarditis [ Time Frame: at Day 45 ]
  8. Number of non clinical investigations (microbial and non microbial) [ Time Frame: at day 30 ]
  9. Length of hospital stay [ Time Frame: at day 30 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00709358

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CHU Henri Mondor
Créteil, France
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Hoffmann-La Roche
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Principal Investigator: Emmanuelle CAMBAU, PH Assistance Publique - Hôpitaux de Paris
Principal Investigator: René COURCOL, PH CHRU LILLE
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Assistance Publique - Hôpitaux de Paris Identifier: NCT00709358    
Other Study ID Numbers: P070308
First Posted: July 3, 2008    Key Record Dates
Last Update Posted: December 29, 2011
Last Verified: May 2011
Keywords provided by Assistance Publique - Hôpitaux de Paris:
real time PCR
adequate antimicrobial therapy
microbial DNA
microbial diagnosis
Additional relevant MeSH terms:
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Febrile Neutropenia
Systemic Inflammatory Response Syndrome
Pathologic Processes
Leukocyte Disorders
Hematologic Diseases
Body Temperature Changes
Heart Diseases
Cardiovascular Diseases