Bacterial Infection Diagnosis Using Blood DNA

NCT00698919 | Unknown

• 2 other identifiers: RCB : 2008-A00361-54PF01743
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 5

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.

Conditions

Infection; Sepsis

Keywords

Bacterial DNA; Systemic inflammatory response syndrome; Infection; Intensive Care Unit

Outcome Measures

Primary Outcomes (1)

• Using PCR we will determine the accuracy of these tests in identifying bacteria or fungi responsible of the infection.

  End of the ICU stay

Secondary Outcomes (1)

• 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)

Study Arms (2)

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

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

Interventions

Observational study OTHER

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.

Development cohort; Validation Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• age \<18 year old.

Sponsors & Collaborators

• Delafontaine Hospital: lead
• Saint-Louis Hospital, Paris, France: collaborator
• Jacques Cartier Institute: collaborator
• Unity Health Toronto: collaborator
• Institut Pasteur: collaborator

Study Sites (5)

Jacques Cartier Institute

Massy, 91300, France

Location

Saint louis Hospital

Paris, 75011, France

Location

Saint Joseph Hospital

Paris, 75674 Cedex14, France

Location

Pasteur Institute

Paris, 75724 Cedex 15, France

Location

Delafontaine Hospital

Saint-Denis, 93205, France

Location

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.

MeSH Terms

Conditions

Infections; Sepsis; Systemic Inflammatory Response Syndrome

Interventions

Observation

Condition Hierarchy (Ancestors)

Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Christophe Adrie, MD

  Delafontaine Hospital

  PRINCIPAL INVESTIGATOR

• Mehran Monchi, MD

  Jacques Cartier Institute

  STUDY DIRECTOR

Central Study Contacts

Christophe Adrie, MD, PhD

CONTACT

33-14-235-6107; christophe.adrie@wanadoo.fr

Jean Marc Cavaillon, ScD

CONTACT

33-14-568-8238; jmcavail@pasteur.fr

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 13, 2008
• First Posted: June 17, 2008
• Study Start: September 1, 2008
• Primary Completion: September 1, 2010
• Study Completion: November 1, 2010
• Last Updated: June 17, 2008

Record last verified: 2008-06

Locations

FR (5)