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Bacterial Infection Diagnosis Using Blood DNA

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ClinicalTrials.gov Identifier: NCT00698919
Recruitment Status : Unknown
Verified June 2008 by Delafontaine Hospital.
Recruitment status was:  Not yet recruiting
First Posted : June 17, 2008
Last Update Posted : June 17, 2008
Sponsor:
Collaborators:
Information provided by:

Study Description
Brief Summary:

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 or disease Intervention/treatment
Infection Sepsis Other: Observational study

  Show Detailed Description

Study Design

Study Type : Observational
Estimated Enrollment : 400 participants
Time Perspective: Prospective
Official Title: Bacterial DNA Detection as a Diagnostic Tool of Infection in Critical Ill Patients With SIRS
Study Start Date : September 2008
Estimated Primary Completion Date : September 2010
Estimated Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Development cohort
A first group of one hundred patients with SIRS will be included to evaluate the accuracy of this new test.
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.

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.
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.



Outcome Measures

Primary Outcome Measures :
  1. Using PCR we will determine the accuracy of these tests in identifying bacteria or fungi responsible of the infection. [ Time Frame: End of the ICU stay ]

Secondary Outcome Measures :
  1. We will examine whether or not cytokines' profile, levels of endotoxin and peptidoglycan help to discriminate infectious from non-infectious SIRS. [ Time Frame: The assays will be done later on (within 6 months) ]

Biospecimen Retention:   Samples With DNA

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.


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • At least SIRS criteria at admission or during ICU stay.

Exclusion Criteria:

  • age <18 year old.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00698919


Contacts
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

Locations
France
Jacques Cartier Institute Not yet recruiting
Massy, France, 91300
Contact: Mehran Monchi, MD    33160136272    m.monchi@free.fr   
Principal Investigator: Mehran Monchi, MD         
Saint louis Hospital Not yet recruiting
Paris, France, 75011
Contact: Elie Azoulay, MD, PhD    331 42 49 46 60    elie.azoulay@sls.ap-hop-paris.fr   
Principal Investigator: Michael Darmon, MD         
Saint Joseph Hospital Not yet recruiting
Paris, France, 75674 Cedex14
Contact: François Philippart, MD    33144123415    fphilippart@gmail.com   
Principal Investigator: François Philippart, MD         
Pasteur Institute Not yet recruiting
Paris, France, 75724 Cedex 15
Contact: Jean Marc Cavaillon, ScD    33145688238    jmcavail@pasteur.fr   
Sub-Investigator: Minou Adib-Conquy, PhD         
Delafontaine Hospital Not yet recruiting
Saint Denis, France, 93205
Contact: Christophe Adrie, MD    33142356107    christophe.adrie@wanadoo.fr   
Contact: Antonio Alvarez Gonzalez, MD    33142356107    pyalvarez@hotmail.com   
Principal Investigator: Antonio Alvarez Gonzalez, MD         
Sponsors and Collaborators
Delafontaine Hospital
Saint-Louis Hospital, Paris, France
Jacques Cartier Institute
St. Joseph Hospital Health Center
Institut Pasteur
Investigators
Principal Investigator: Christophe Adrie, MD Delafontaine Hospital
Study Director: Mehran Monchi, MD Jacques Cartier Institute
More Information

Responsible Party: Christophe Adrie, MD, PhD, RER Saint Denis
ClinicalTrials.gov Identifier: NCT00698919     History of Changes
Other Study ID Numbers: RCB : 2008-A00361-54
PF01743
First Posted: June 17, 2008    Key Record Dates
Last Update Posted: June 17, 2008
Last Verified: June 2008

Keywords provided by Delafontaine Hospital:
Bacterial DNA
Systemic inflammatory response syndrome
Infection
Intensive Care Unit

Additional relevant MeSH terms:
Infection
Communicable Diseases