Skip to main content
OpenTrials
Completed

NCT Number: NCT00561639

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?

Completed

Looking for future studies?

Notify Me

Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Grenoble

Grenoble, 38043, France

About this study

This study has double purpose :

  • To compare the results obtained from the SeptiFast system with the results from classical microbiological sampling, in particular hemoculture, for immunosuppressed patients presenting sepsis.
  • To perform a blind assessment of the benefit of septiFast care of these patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

University Hospital, Grenoble

Other

Registry information

Acronym: SEPTIFAST

Important dates

Study start
2007
Study completion
2008
First posted
Nov 21, 2007
Registry last updated
Jul 9, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.