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Study of Procalcitonin (PCT)-Guided Antibiotic Use in Severe Sepsis Patients Without Obvious Infection (Pro-SEPS)

This study has been terminated.
(65 patients were included after 2 years instead of 140)
Sponsor:
Information provided by:
Brahms France
ClinicalTrials.gov Identifier:
NCT01025180
First received: December 1, 2009
Last updated: December 3, 2010
Last verified: December 2009

December 1, 2009
December 3, 2010
December 2007
January 2010   (final data collection date for primary outcome measure)
rate of patients undergoing antibiotic treatment at D5. [ Time Frame: at D5 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01025180 on ClinicalTrials.gov Archive Site
evolution of the SOFA score between D0, D3 and D5. [ Time Frame: D30 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Study of Procalcitonin (PCT)-Guided Antibiotic Use in Severe Sepsis Patients Without Obvious Infection
Randomized Multicentre Prospective Study of Procalcitonin-guided Treatment on Antibiotic Use and Outcome in Severe Sepsis ICU Patients Without Obvious Infection

A recent study has demonstrated that in low respiratory infections, a strategy using prescription of antibiotics based on the pro-calcitonin level allows decreasing recourse to antibiotics by 47% without prognostic modification.

The aim is to evaluate the impact on antibiotics consumption of an algorithm using procalcitonin level in patients exhibiting severe sepsis symptomatology but without clearly identified hosted germs or infectious centre.

This multicenter study is a randomized prospective open study involving 9 ICU departments in France, comparing two strategies on antibiotherapy treatment period one based on procalcitonin level(experimental group) the other on physician's appreciation(control group)

140 adult patients should be included with a severe sepsis symptomatology, whose infectious etiology has not been proven. The main non-inclusion criterium is: the presence of a pathogen agent or infectious centre clearly identified.

The primary outcome is the rate of patients undergoing antibiotic treatment at D5.

Secondary outcomes: duration of the antibiotic treatment, mortality rate and duration in stay in intensive care ward and evolution of the SOFA score between D0, D3 and D5.

Duration of patient enrollment is 30 days.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Severe Sepsis
Other: Procalcitonin level

The duration of antibiotic treatment is based on PCT level:

  • < 0.25 ng/ml: antibiotic should be stopped
  • 0.25 < PCT <0.5: antibiotic prescription is not recommended
  • > 0.5 ng/ml: antibiotic should be used
  • Procalcitonin level
    duration of the antibiotic treatment guided by procalcitonin level
    Intervention: Other: Procalcitonin level
  • No Intervention: physician's appreciation
    duration of the antibiotic treatment based on physician's appreciation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
62
March 2010
January 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • hospitalized in resuscitation ward
  • severe sepsis symptomatology
  • at least 2 SIRS criteria
  • no infectious etiology detected
  • at least one organ deficiency

Exclusion Criteria:

  • the presence of a pathogen agent or infectious centre clearly identified
  • pregnancy
  • burned
  • patients with therapeutic limitation
  • recent surgery
  • secondary neutropenia
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01025180
PCT-F-2005-10
Yes
Djillali Annane/ Professor, Coordinator and Principal Investigator
Brahms France
Not Provided
Principal Investigator: Djillali Annane, Professor Raymond Poincaré hospital Garches-France
Brahms France
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP