An interventional study of Procalcitonin guided strategy in Bacterial Infections, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-11-25.
Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Diagnostic
The study is a prospective, randomized, controlled intervention trial conducted in 9 centers, comparing a conventional strategy versus a PCT-guided strategy to start or to discontinue antibiotics, in patients with suspected community or hospital- acquired infection.
Clinical and laboratory signs are neither specific nor sensitive for diagnosis of sepsis in critically-ill patients. Because delaying antimicrobial therapy may be deleterious, broad-spectrum antibiotics are widely used in ICU -patients, even when they are not needed. In addition, only few well-designed studies concerning the duration of antibiotic treatment have been so far published. Consequently, many patients received antibiotics during the ICU stay. Many studies have shown that exposure to antibiotics, the so called "selection pressure" is an independent risk factor for acquisition of resistance in individual patients. Therefore, reducing antibiotic use is probably necessary to control antibiotic resistance. Many clinical studies have shown that procalcitonin (PCT) is able to distinguish the inflammatory response to infection from other types of inflammation and to distinguish bacterial from viral infections. Recent studies have shown that PCT guidance substantially and safely reduced antibiotic overuse in patients with lower respiratory tract infections. We aimed to evaluate the role of PCT in reducing the use of antibiotics in ICU adult patients. The study is a prospective, randomized, controlled intervention trial conducted in 9 centers, comparing a conventional strategy versus a PCT-guided strategy to start or to discontinue antibiotics, in patients with suspected community or hospital- acquired infection.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 630 is above the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
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Exclusion Criteria:
Procalcitonin guided strategy
Procedure: Procalcitonin guided strategy
Procalcitonin guided strategy
Exposition to antibiotics, defined by antibiotic-free days
Time frame: assessed 28 days after inclusion
Mortality
Time frame: at Day 28 and Day 60
Consumption of antibiotics expressed as the Defined Daily Dose/1000 ICU-days
Time frame: between D1 and D28
The length of ICU and hospital stay
Time frame: during the stay at the hospital
The evolution of SOFA score parameters
Time frame: between D1 and D28
The number of mechanical ventilation-free days
Time frame: at D28
The acquisition cost of antibiotics
Time frame: between D1 and D28
The percentage of emerging multiresistant bacteria between D1 and D28, as assessed by microbiologic examination of all clinical samples.
Time frame: between D1 and D28
The percentages of relapses of infection
Time frame: between D1 and D28
This study is completed, as verified in May 2007. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris