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| Descriptive Information Fields | |||||||||
| Brief Title † | Diagnosis of Septicaemia by Detection of Microbial DNA in Blood in Severe Infections | ||||||||
| 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 | ||||||||
| 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. |
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| 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 Phase | Phase IV | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Diagnostic, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study | ||||||||
| Primary Outcome Measure † | Number of bacteraemia and of fungemia - overall - each condition [ Time Frame: max Day 30 ] [ Designated as safety issue: Yes ] | ||||||||
| Secondary Outcome Measure † | Number of patients with adequate anti-infective therapy [ Time Frame: at day 30 ] [ Designated as safety issue: Yes ] Adequate anti-infective therapy [ Time Frame: at 24h, 48h, > 48h ] [ Designated as safety issue: Yes ] Time between sampling for microbial investigation and positive results relevant for the diagnosis [ Time Frame: between sampling for microbial investigation and positive results ] [ Designated as safety issue: Yes ] Mortality [ Time Frame: at Day 30 ] [ Designated as safety issue: Yes ] Sepsis chock, secondary infectious focus [ Time Frame: at Day 30 ] [ Designated as safety issue: Yes ] For neutropenia cases, number of patients who evaluated with a clinical focus of infection [ Time Frame: at day 30 ] [ Designated as safety issue: Yes ] Diagnosis of endocarditis [ Time Frame: at Day 45 ] [ Designated as safety issue: Yes ] Number of non clinical investigations (microbial and non microbial) [ Time Frame: at day 30 ] [ Designated as safety issue: Yes ] Length of hospital stay [ Time Frame: at day 30 ] [ Designated as safety issue: Yes ] |
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| Condition † | Febrile Neutropenia Suspicion of Endocarditis Severe Sepsis in Intensive Care Unit |
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| Intervention † | Other: Detection of microbial DNA in blood by SeptiFast® Other: detection of microbial DNA in blood by blood culture |
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| MEDLINE PMIDs | |||||||||
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 2000 | ||||||||
| Start Date † | May 2008 | ||||||||
| Completion Date | March 2010 | ||||||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts †† |
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| Location Countries † | France | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00709358 | ||||||||
| Organization ID | P070308 | ||||||||
| Secondary IDs †† | |||||||||
| Study Sponsor † | Assistance Publique - Hôpitaux de Paris | ||||||||
| Collaborators †† | Hoffmann-La Roche | ||||||||
| Investigators † |
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| Information Provided By | Assistance Publique - Hôpitaux de Paris | ||||||||
| Verification Date | October 2008 | ||||||||
| First Received Date † | July 2, 2008 | ||||||||
| Last Updated Date | November 24, 2008 | ||||||||
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