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| Sponsor: | Assistance Publique - Hôpitaux de Paris |
|---|---|
| Collaborator: |
Hoffmann-La Roche |
| Information provided by (Responsible Party): | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT00709358 |
Purpose
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 | Intervention | 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 IV |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: 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 |
| Enrollment: | 2000 |
| Study Start Date: | May 2008 |
| Study Completion Date: | September 2010 |
| Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 2
Detection by blood culture
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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.
Other Name: detection of microbial DNA in blood by blood culture
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Experimental: 1
Test LightCycler SeptiFast® (Roche)
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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. Other Name: Detection of microbial DNA in blood by SeptiFast®
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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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| France | |
| CHU Henri Mondor | |
| Créteil, France | |
| Principal Investigator: | Emmanuelle CAMBAU, PH | Assistance Publique - Hôpitaux de Paris |
| Principal Investigator: | René COURCOL, PH | CHRU LILLE |
More Information
| Responsible Party: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT00709358 History of Changes |
| Other Study ID Numbers: | P070308 |
| Study First Received: | July 2, 2008 |
| Last Updated: | December 26, 2011 |
| Health Authority: | France: Ministry of Health |
|
bacteria fungi real time PCR |
adequate antimicrobial therapy microbial DNA microbial diagnosis |
|
Endocarditis Fever Neutropenia Sepsis Toxemia Heart Diseases Cardiovascular Diseases Body Temperature Changes Signs and Symptoms |
Agranulocytosis Leukopenia Leukocyte Disorders Hematologic Diseases Infection Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes |
