Clinical trial NCT00561639: Benefit of SeptiFast Multiplex PCR in the Etiologic Diagnosis and Therapeutic Approach for Onco-hematology Patients Presenting Sepsis
Official title: Benefit of Septifast Multiplex PCR in the Etiologic Diagnosis and Therapeutic Approach for Onco-hematology Patients Presenting Sepsis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hematologic Diseases
Sepsis
Keywords: sepsis
immunosuppressed
multiplex PCR
diagnosis
therapeutic
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2007-11-21
Enrollment: 76
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Grenoble
country: France
facility: University Hospital of Grenoble
Study officials:
affiliation: University Hospital, Grenoble
name: TIMSIT Jean-François, PU/PH
role: PRINCIPAL_INVESTIGATOR
References: