Text Size

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
History of Changes
  Purpose

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?


Condition
Hematologic Diseases
Sepsis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Benefit of Septifast Multiplex PCR in the Etiologic Diagnosis and Therapeutic Approach for Onco-hematology Patients Presenting Sepsis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Grenoble:

Biospecimen Retention:   Samples Without DNA

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


Enrollment: 76
Study Start Date: December 2007
Study Completion Date: November 2008
Detailed Description:

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.
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00561639

Locations
France
University Hospital of Grenoble
Grenoble, France, 38043
Sponsors and Collaborators
University Hospital, Grenoble
Investigators
Principal Investigator: TIMSIT Jean-François, PU/PH University Hospital, Grenoble
  More Information

No publications provided

Responsible Party: TIMSIT, University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT00561639     History of Changes
Other Study ID Numbers: 2007-A01053-50
Study First Received: November 20, 2007
Last Updated: July 8, 2010
Health Authority: France: Institutional Ethical Committee
France: Direction Générale de la Santé

Keywords provided by University Hospital, Grenoble:
sepsis
immunosuppressed
multiplex PCR
diagnosis
therapeutic

Additional relevant MeSH terms:
Hematologic Diseases
Sepsis
Toxemia
Infection
 Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on June 18, 2013