Benefit of SeptiFast Multiplex PCR in the Etiologic Diagnosis and Therapeutic Approach for Onco-hematology Patients Presenting Sepsis (SEPTIFAST)

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Grenoble
ClinicalTrials.gov Identifier:
NCT00561639
First received: November 20, 2007
Last updated: July 8, 2010
Last verified: July 2010

November 20, 2007
July 8, 2010
December 2007
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00561639 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Benefit of SeptiFast Multiplex PCR in the Etiologic Diagnosis and Therapeutic Approach for Onco-hematology Patients Presenting Sepsis
Benefit of Septifast Multiplex PCR in the Etiologic Diagnosis and Therapeutic Approach for Onco-hematology Patients Presenting Sepsis

A SpetiFast multiplex PCR kit has recently been placed on the market witch can evidence the DNA of 90% of micro-organisms (bacteria and fungus) implicated in sepsis. However, the clinical impact of being able to detect the DNA of these various agents is unknown. We propose to assess the benefit to patient care of the SeptiFast multiples PCR by answering three questions : 1/in patients with septic immunosuppression, does this kit evidence etiologic agents not revealed by classical methods? 2/Does the use of PCR results permit different diagnostic hypotheses to be considered? 3/Does having the SeptiFast results entail changes to the therapeutic plan?

This study has double purpose :

  1. To compare the results obtained from the SeptiFast system with the results from classical microbiological sampling, in particular hemoculture, for immunosuppressed patients presenting sepsis.
  2. To perform a blind assessment of the benefit of septiFast care of these patients.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

serum tube will routinely be kept in the serum bank for subsequent analysis

Non-Probability Sample

All patients with onco-hematologic or cancerous pathology, or hematologic disease with chemotherapy and/or radiotherapy and/or some other immunosuppressant treatment in progress presenting an infection requiring hospitalisation and meeting the following criteria : Sepsis and with or without organ dysfunction

  • Hematologic Diseases
  • Sepsis
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
76
November 2008
Not Provided

Inclusion Criteria:

All patients with onco-hematologic or cancerous pathology, or hematologic disease with chemotherapy and/or radiotherapy and/or some other immunosuppressant treatment in progress presenting an infection requiring hospitalisation and meeting the following criteria:

  • Sepsis (at least one of the following signs):

    • Fever > 38.2°C or hypothermia < 36°C
    • FO120 min
    • PA<120 mmHg (or 50 mmHg reduction in base numbers)
    • Respiratory F > 30/min
    • Confusion
    • Hyperleucocytosis (>12 G/l) or leucopenia (<4 G/l)
    • C-Reactive protein > 40
  • With or without organ dysfunction as defined by :

    • Hypoxia (PaO2/FiO2<300mmHg)
    • Oliguria (urine deficiency<0.5 ml/kg/h in probed patient)
    • Creatinine > 200umol/l
    • INR>1.5 or TCA>2 X control in the absence of anticoagulant treatment
    • Platelets < 100 G/l
    • Bilirubin > 35 umol/l
    • Lactatemia > 2 mmol/l
    • Arterial hypotension (PAS<90mmHg, or PAM<70mmHg or reduction of more than 40 mmHG if known hypertension)

Exclusion Criteria:

  • Minor patient
  • Pregnancy
  • A patient cannot be included again within 15 days of his/her preceding inclusion
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00561639
2007-A01053-50
Yes
TIMSIT, University Hospital, Grenoble
University Hospital, Grenoble
Not Provided
Principal Investigator: TIMSIT Jean-François, PU/PH University Hospital, Grenoble
University Hospital, Grenoble
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP