Sepsis Clinical Trial
Official title:
Bacterial DNA Detection as a Diagnostic Tool of Infection in Critical Ill Patients With SIRS
Sepsis is a common cause of morbidity and death in intensive care units. Clinical and
laboratory signs of systemic inflammation, including changes in body temperature,
tachycardia, or leukocytosis, are neither sensitive nor specific enough for the diagnosis of
sepsis. The diagnosis of sepsis is difficult, because clinical signs are unspecific. These
signs include tachycardia, leucocytosis, tachypnoea, and pyrexia, which are collectively
termed a systemic inflammatory response syndrome (SIRS). SIRS is very common in critically
ill patients, being found in various conditions including trauma, surgery, burns,
pancreatitis, post-cardiac arrest syndrome, cardiac surgery. Microbiological culture can be
used to distinguish sepsis from non-infectious conditions. However, this method lacks
sensitivity and specificity, and there is often a substantial time delay. So these signs can
also be misleading because critically ill patients often present with the systemic
inflammatory response syndrome without infection. This issue is of paramount importance,
since therapy and outcome differ greatly between patients with and those without sepsis;
clinicians are often prone to overuse antibiotic therapy being afraid of not treating a
potential infection or superinfection. Moreover, the widespread use of antibiotics for all
such patients is likely to increase antibiotic resistance, toxicity, and costs. On the
opposite, any delay in administration of antibiotics can be extremely detrimental for the
infected patient with an exponential increase of the odd ratio for death. Search for early
biomarker tools for the diagnosis of infection, initially promising, are quite challenged
and controversial nowadays because they can be more related to the inflammation response,
irrespective to the insult. Furthermore up to 40% of the infections remain strongly
suspected but not bacteriologically documented. Persisting researches are ongoing to find
new markers to better discriminate SIRS related to infection process from to SIRS not
related to infection. Cytokine profiles using multiplex analysis seems more related to the
severity of the SIRS than the trigger of the SIRS (infectious or non infectious diseases).
Thus, new tools have been developed to identify bacteria by detecting their DNA by various
techniques. These techniques have many potential interests over conventional microbiologic
tests by decreasing turnaround time (within a few hours 2-6 hours), reducing inhibitory
effects of prior use of antibiotics, detection of slow or fastidious growing organisms.
However these tests remain to be validated in a clinical setting.
The goal of the current study is to evaluate the diagnostic value of plasma detection of
bacterial DNA in ICU patients with a clinical suspicion of bacterial infection.
Status | Not yet recruiting |
Enrollment | 400 |
Est. completion date | November 2010 |
Est. primary completion date | September 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - At least SIRS criteria at admission or during ICU stay. Exclusion Criteria: - age <18 year old. |
Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
France | Jacques Cartier Institute | Massy | |
France | Pasteur Institute | Paris | |
France | Saint Joseph Hospital | Paris | |
France | Saint louis Hospital | Paris | |
France | Delafontaine Hospital | Saint Denis |
Lead Sponsor | Collaborator |
---|---|
Delafontaine Hospital | Institut Pasteur, Jacques Cartier Institute, Saint-Louis Hospital, Paris, France, St. Joseph Hospital Health Center |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Using PCR we will determine the accuracy of these tests in identifying bacteria or fungi responsible of the infection. | End of the ICU stay | No | |
Secondary | We will examine whether or not cytokines' profile, levels of endotoxin and peptidoglycan help to discriminate infectious from non-infectious SIRS. | The assays will be done later on (within 6 months) | No |
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