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

Sponsor:	Assistance Publique - Hôpitaux de Paris
Information provided by:	Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:	NCT00472667

Purpose

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.

Condition	Intervention
Bacterial Infections	Procedure: Procalcitonin guided strategy

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Factorial Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Impact of Procalcitonin to Reduce Antibiotics Use in ICU Adults Patients

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics Bacterial Infections

Drug Information available for: Procalcitonin

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:

Exposition to antibiotics, defined by antibiotic-free days [ Time Frame: assessed 28 days after inclusion ] [ Designated as safety issue: Yes ]
Mortality [ Time Frame: at Day 28 and Day 60 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Consumption of antibiotics expressed as the Defined Daily Dose/1000 ICU-days [ Time Frame: between D1 and D28 ] [ Designated as safety issue: Yes ]
The length of ICU and hospital stay [ Time Frame: during the stay at the hospital ] [ Designated as safety issue: No ]
The evolution of SOFA score parameters [ Time Frame: between D1 and D28 ] [ Designated as safety issue: No ]
The number of mechanical ventilation-free days [ Time Frame: at D28 ] [ Designated as safety issue: No ]
The acquisition cost of antibiotics [ Time Frame: between D1 and D28 ] [ Designated as safety issue: No ]
The percentage of emerging multiresistant bacteria between D1 and D28, as assessed by microbiologic examination of all clinical samples. [ Time Frame: between D1 and D28 ] [ Designated as safety issue: No ]
The percentages of relapses of infection [ Time Frame: between D1 and D28 ] [ Designated as safety issue: No ]

Enrollment:	630
Study Start Date:	July 2007
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Procalcitonin guided strategy	Procedure: Procalcitonin guided strategy Procalcitonin guided strategy Other Name: 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00472667

Locations

France
Chu Bichat Claude Bernard
Paris, France, 75018

Sponsors and Collaborators

Assistance Publique - Hôpitaux de Paris

Investigators

Principal Investigator:

Lila BOUADMA, MD

Assistance Publique - Hôpitaux de Paris

More Information

No publications provided by Assistance Publique - Hôpitaux de Paris

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Bouadma L, Luyt CE, Tubach F, Cracco C, Alvarez A, Schwebel C, Schortgen F, Lasocki S, Veber B, Dehoux M, Bernard M, Pasquet B, Régnier 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. Epub 2010 Jan 25.

Responsible Party:	Aurelie GUIMFACK, Department Clinical Research of Developpement
ClinicalTrials.gov Identifier:	NCT00472667 History of Changes
Other Study ID Numbers:	P060204, AOR06019
Study First Received:	May 11, 2007
Last Updated:	November 24, 2008
Health Authority:	France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:

Bacterial infections
Procalcitonin
Intensive care unit
Antibiotic therapy
Suspicion of bacterial infection or proven

Additional relevant MeSH terms:

Bacterial Infections
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2012