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Sponsors and Collaborators: |
Delafontaine Hospital Saint-Louis Hospital Jacques Cartier Institute St. Joseph Hospital Institut Pasteur |
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Information provided by: | Delafontaine Hospital |
ClinicalTrials.gov Identifier: | NCT00698919 |
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.
Condition | Intervention |
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Infection Sepsis |
Other: Observational study |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | Bacterial DNA Detection as a Diagnostic Tool of Infection in Critical Ill Patients With SIRS |
Sample with bacterial DNA (and no human DNA will be studied)
We will have also some blood and plasma for cytokines,peptidoglycan and endotoxin measurement.
Estimated Enrollment: | 400 |
Study Start Date: | September 2008 |
Estimated Study Completion Date: | November 2010 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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Development cohort
A first group of one hundred patients with SIRS will be included to evaluate the accuracy of this new test.
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Other: Observational study
This is not an interventional studies. We will just compare two methods of bacterial diagnosis. Of note the physicians will care of their patients with the classic bacterial analysis tools; so there is no modification of the care. The new techniques used (DNA detection) will done later on and thus won't modify their decision.
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Validation Cohort
Depending on the result of the previous (development) cohort we will more accurately evaluate the need of number of patients with SIRS to include in the second cohort of patients.
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Other: Observational study
This is not an interventional studies. We will just compare two methods of bacterial diagnosis. Of note the physicians will care of their patients with the classic bacterial analysis tools; so there is no modification of the care. The new techniques used (DNA detection) will done later on and thus won't modify their decision.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
All ICU patients older than 18 years old, with a SIRS, severe sepsis or septic shock will be included in this cohort study. SIRS, Severe sepsis and shock septic will be defined according to the definition used by a panel of experts from the American College of Chest Physicians/Society of Critical Care Medicine
Inclusion Criteria:
Exclusion Criteria:
Contact: Christophe Adrie, MD, PhD | 33-14-235-6107 | christophe.adrie@wanadoo.fr |
Contact: Jean Marc Cavaillon, ScD | 33-14-568-8238 | jmcavail@pasteur.fr |
France | |
Delafontaine Hospital | |
Saint Denis, France, 93205 | |
Jacques Cartier Institute | |
Massy, France, 91300 | |
Saint Joseph Hospital | |
Paris, France, 75674 Cedex14 | |
Saint louis Hospital | |
Paris, France, 75011 | |
Pasteur Institute | |
Paris, France, 75724 Cedex 15 |
Principal Investigator: | Christophe Adrie, MD | Delafontaine Hospital |
Study Director: | Mehran Monchi, MD | Jacques Cartier Institute |
Responsible Party: | RER Saint Denis ( Christophe Adrie, MD, PhD ) |
Study ID Numbers: | RCB : 2008-A00361-54, PF01743 |
Study First Received: | June 13, 2008 |
Last Updated: | June 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00698919 History of Changes |
Health Authority: | France: Ministry of Health; France: Institutional Ethical Committee |
Bacterial DNA Systemic inflammatory response syndrome Infection Intensive Care Unit |
Systemic Inflammatory Response Syndrome Bacterial Infections Sepsis |
Communicable Diseases Infection |