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Clinical Trials/NCT01025180
NCT01025180
Terminated
Phase 4

Randomized Multicentre Prospective Study of Procalcitonin-guided Treatment on Antibiotic Use and Outcome in Severe Sepsis ICU Patients Without Obvious Infection

Brahms France9 sites in 1 country62 target enrollmentDecember 2007
ConditionsSevere Sepsis

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Severe Sepsis
Sponsor
Brahms France
Enrollment
62
Locations
9
Primary Endpoint
rate of patients undergoing antibiotic treatment at D5.
Status
Terminated
Last Updated
15 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
December 2007
End Date
March 2010
Last Updated
15 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Brahms France

Eligibility Criteria

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
  • patients with therapeutic limitation
  • recent surgery
  • secondary neutropenia

Outcomes

Primary Outcomes

rate of patients undergoing antibiotic treatment at D5.

Time Frame: at D5

Secondary Outcomes

  • evolution of the SOFA score between D0, D3 and D5.(D30)

Study Sites (9)

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