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

Sepsis Clinical Trial

— SEPTIFAST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00561639
• Other study ID #: 2007-A01053-50
• Status: Completed
• Phase: N/A
• First received: November 20, 2007
• Last updated: July 8, 2010
• Start date: December 2007
• Est. completion date: November 2008

Study information

• Verified date: July 2010
• Source: University Hospital, Grenoble
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Institutional Ethical CommitteeFrance: Direction Générale de la Santé
• Study type: Observational

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hematologic Diseases
• Sepsis
• Toxemia

Locations

Country	Name	City	State
France	University Hospital of Grenoble	Grenoble

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Grenoble

Country where clinical trial is conducted

France,