PROcalcitonin Reduce Antibiotic Treatments in Acute-Ill Patients (PRORATA)

Not Applicable

Completed

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Inclusion Criteria

Patient hospitalised in the ICU
Bacterial infection suspected
At ICU admission the patient do not receive antibiotics or receive antibiotics for less than 24hours and an interval between admission and inclusion < 12 hours
During ICU stay, provided that the interval between the start of suspected infection and inclusion is < 12hours
Written inform consent from the patient or relatives. The consent may be obtained after the enrollment if the patient is not able to give consent and if there is no relatives

Exclusion Criteria

Age < 18 years
Pregnancy
Patient expected to remain hospitalised in the ICU for less than 3 days
Neutropenia
Infection or presumed infection requiring prolonged antibiotic therapy (endocarditis,osteo-articular infection, mediastinitis, deep abscess, tuberculosis, pneumocystis pneumonia, toxoplasmosis).
Simplified Acute Physiology Score II at ICU admission (calculated during the first 12h)
Attending physician declining to use full life support.

Arm && Interventions

Group	Intervention	Description
1	Procalcitonin guided strategy	Procalcitonin guided strategy

Primary Outcome Measures

Name	Time	Method
Exposition to antibiotics, defined by antibiotic-free days	assessed 28 days after inclusion
Mortality	at Day 28 and Day 60

Secondary Outcome Measures

Name	Time	Method
Consumption of antibiotics expressed as the Defined Daily Dose/1000 ICU-days	between D1 and D28
The length of ICU and hospital stay	during the stay at the hospital
The evolution of SOFA score parameters	between D1 and D28
The number of mechanical ventilation-free days	at D28
The acquisition cost of antibiotics	between D1 and D28
The percentage of emerging multiresistant bacteria between D1 and D28, as assessed by microbiologic examination of all clinical samples.	between D1 and D28
The percentages of relapses of infection	between D1 and D28

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