Bacterial Infections
Conditions
Keywords
Bacterial infections, Procalcitonin, Intensive care unit, Antibiotic therapy, Suspicion of bacterial infection or proven
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.
Interventions
PROCEDUREProcalcitonin guided strategy
Procalcitonin guided strategy
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Exposition to antibiotics, defined by antibiotic-free days | assessed 28 days after inclusion |
| Mortality | at Day 28 and Day 60 |
Secondary
| Measure | Time frame |
|---|---|
| The percentage of emerging multiresistant bacteria between D1 and D28, as assessed by microbiologic examination of all clinical samples. | between D1 and D28 |
| Consumption of antibiotics expressed as the Defined Daily Dose/1000 ICU-days | between D1 and D28 |
| The percentages of relapses of infection | between D1 and D28 |
| The evolution of SOFA score parameters | between D1 and D28 |
| The number of mechanical ventilation-free days | at D28 |
| The length of ICU and hospital stay | during the stay at the hospital |
| The acquisition cost of antibiotics | between D1 and D28 |
Countries
France
Outcome results
None listed