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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Impact of Procalcitonin to Reduce Antibiotics Use in ICU Adults Patients

Conditions
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Bacterial Infections

Intervention / Treatment
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* Procedure: Procalcitonin guided strategy


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Procalcitonin guided strategy | Procedure: Procalcitonin guided strategy<br>* Procalcitonin guided strategy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exposition to antibiotics, defined by antibiotic-free days |  | assessed 28 days after inclusion | 
| Mortality |  | at Day 28 and Day 60 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bacterial infections, Procalcitonin, Intensive care unit, Antibiotic therapy, Suspicion of bacterial infection or proven