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

Impact of Procalcitonin to Reduce Antibiotics Use in ICU Adults 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.

Study Overview

• Status: Completed
• Conditions: Bacterial Infections
• Intervention / Treatment: Procedure: Procalcitonin guided strategy

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.

• Study Type: Interventional
• Enrollment (Actual): 630
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75018
    • Chu Bichat Claude Bernard

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Procalcitonin guided strategy	Procedure: Procalcitonin guided strategy; Procalcitonin guided strategy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Lila BOUADMA, MD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2007
• Primary Completion (Actual): May 1, 2008
• Study Completion (Actual): May 1, 2008

Study Registration Dates

• First Submitted: May 11, 2007
• First Submitted That Met QC Criteria: May 11, 2007
• First Posted (Estimate): May 14, 2007

Study Record Updates

• Last Update Posted (Estimate): November 25, 2008
• Last Update Submitted That Met QC Criteria: November 24, 2008
• Last Verified: May 1, 2007

More Information

Terms related to this study

• Keywords: Procalcitonin; Intensive care unit; Bacterial infections; Antibiotic therapy; Suspicion of bacterial infection or proven
• Additional Relevant MeSH Terms: Bacterial Infections and Mycoses; Infections; Bacterial Infections
• Other Study ID Numbers: P060204; AOR06019