Severe Sepsis Clinical Trial
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
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.
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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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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