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

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?

Study Overview

• Status: Completed
• Conditions: Sepsis; Hematologic Diseases

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.

• Study Type: Observational
• Enrollment (Actual): 76

Contacts and Locations

Study Locations

• France
  • Grenoble, France, 38043
    • University hospital of Grenoble

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Investigators: Principal Investigator: TIMSIT Jean-François, PU/PH, University Hospital, Grenoble

Study record dates

Study Major Dates

• Study Start: December 1, 2007
• Primary Completion: December 7, 2022
• Study Completion (Actual): November 1, 2008

Study Registration Dates

• First Submitted: November 20, 2007
• First Submitted That Met QC Criteria: November 20, 2007
• First Posted (Estimate): November 21, 2007

Study Record Updates

• Last Update Posted (Estimate): July 9, 2010
• Last Update Submitted That Met QC Criteria: July 8, 2010
• Last Verified: July 1, 2010

More Information

Terms related to this study

• Keywords: sepsis; diagnosis; immunosuppressed; multiplex PCR; therapeutic
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia; Hematologic Diseases
• Other Study ID Numbers: 2007-A01053-50

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No