Severe Sepsis Clinical Trial
— EVAMICAOfficial 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
Verified date | May 2011 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | France: Ministry of Health |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 2000 |
Est. completion date | September 2010 |
Est. primary completion date | September 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
France | CHU Henri Mondor | Créteil |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris | Hoffmann-La Roche |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of bacteraemia and of fungemia - overall - each condition | max Day 30 | Yes | |
Secondary | Number of patients with adequate anti-infective therapy | at day 30 | Yes | |
Secondary | Adequate anti-infective therapy | at 24h, 48h, > 48h | Yes | |
Secondary | Time between sampling for microbial investigation and positive results relevant for the diagnosis | between sampling for microbial investigation and positive results | Yes | |
Secondary | Mortality | at Day 30 | Yes | |
Secondary | Sepsis chock, secondary infectious focus | at Day 30 | Yes | |
Secondary | For neutropenia cases, number of patients who evaluated with a clinical focus of infection | at day 30 | Yes | |
Secondary | Diagnosis of endocarditis | at Day 45 | Yes | |
Secondary | Number of non clinical investigations (microbial and non microbial) | at day 30 | Yes | |
Secondary | Length of hospital stay | at day 30 | Yes |
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