Severe Sepsis Clinical Trial
Official title:
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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