Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| AOR06019 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Procalcitonin guided strategy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Procalcitonin guided strategy | Procedure | Procalcitonin guided strategy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Exposition to antibiotics, defined by antibiotic-free days | assessed 28 days after inclusion | |
| Mortality | at Day 28 and Day 60 |
| 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 | |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lila BOUADMA, MD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Bichat Claude Bernard | Paris | 75018 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20097417 | Derived | Bouadma L, Luyt CE, Tubach F, Cracco C, Alvarez A, Schwebel C, Schortgen F, Lasocki S, Veber B, Dehoux M, Bernard M, Pasquet B, Regnier B, Brun-Buisson C, Chastre J, Wolff M; PRORATA trial group. Use of procalcitonin to reduce patients' exposure to antibiotics in intensive care units (PRORATA trial): a multicentre randomised controlled trial. Lancet. 2010 Feb 6;375(9713):463-74. doi: 10.1016/S0140-6736(09)61879-1. Epub 2010 Jan 25. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001424 | Bacterial Infections |
| ID | Term |
|---|---|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |