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

Bacterial Infections Clinical Trial

— PRORATA  

Official title:

Impact of Procalcitonin to Reduce Antibiotics Use in ICU Adults Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00472667
• Other study ID #: P060204
• Secondary ID: AOR06019
• Status: Completed
• Phase: N/A
• First received: May 11, 2007
• Last updated: November 24, 2008
• Start date: July 2007
• Est. completion date: May 2008

Study information

• Verified date: May 2007
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 630
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Bacterial Infections

Intervention

Procedure:
• Procalcitonin guided strategy
Procalcitonin guided strategy

Locations

Country	Name	City	State
France	Chu Bichat Claude Bernard	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exposition to antibiotics, defined by antibiotic-free days		assessed 28 days after inclusion	Yes
Primary	Mortality		at Day 28 and Day 60	No
Secondary	Consumption of antibiotics expressed as the Defined Daily Dose/1000 ICU-days		between D1 and D28	Yes
Secondary	The length of ICU and hospital stay		during the stay at the hospital	No
Secondary	The evolution of SOFA score parameters		between D1 and D28	No
Secondary	The number of mechanical ventilation-free days		at D28	No
Secondary	The acquisition cost of antibiotics		between D1 and D28	No
Secondary	The percentage of emerging multiresistant bacteria between D1 and D28, as assessed by microbiologic examination of all clinical samples.		between D1 and D28	No
Secondary	The percentages of relapses of infection		between D1 and D28	No