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

NCT ID: NCT00561639

Last Updated: 2010-07-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 76 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2008-11-30

Brief Summary

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?

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.

Conditions

Hematologic Diseases; Sepsis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility 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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Grenoble

OTHER

Sponsor Role: lead

Responsible Party

University Hospital, Grenoble

Principal Investigators

TIMSIT Jean-François, PU/PH

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Grenoble

Locations

University Hospital of Grenoble

Grenoble, , France

Countries

France

Other Identifiers

2007-A01053-50

Identifier Type: -

Identifier Source: org_study_id