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

This study has been completed.
Sponsor:
Information provided by:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00472667
First received: May 11, 2007
Last updated: November 24, 2008
Last verified: May 2007

May 11, 2007
November 24, 2008
July 2007
May 2008   (final data collection date for primary outcome measure)
  • 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 ]
  • Exposition to antibiotics, defined by antibiotic-free days [ Time Frame: assessed 28 days after inclusion ]
  • Mortality [ Time Frame: at Day 28 and Day 60 ]
Complete list of historical versions of study NCT00472667 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 1) Consumption of antibiotics expressed as the Defined Daily Dose/1000 ICU-days [ Time Frame: between D1 and D28 ]
  • The length of ICU and hospital stay [ Time Frame: during the stay at the hospital ]
  • The evolution of SOFA score parameters [ Time Frame: between D1 and D28 ]
  • The number of mechanical ventilation-free days [ Time Frame: at D28 ]
  • The acquisition cost of antibiotics [ Time Frame: between D1 and D28 ]
  • 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 ]
  • The percentages of relapses of infection [ Time Frame: between D1 and D28 ]
Not Provided
Not Provided
 
PROcalcitonin Reduce Antibiotic Treatments in Acute-Ill Patients (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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Bacterial Infections
Procedure: Procalcitonin guided strategy
Procalcitonin guided strategy
Other Name: Procalcitonin guided strategy
Experimental: 1
Procalcitonin guided strategy
Intervention: Procedure: Procalcitonin guided strategy
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. doi: 10.1016/S0140-6736(09)61879-1. Epub 2010 Jan 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
630
May 2008
May 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00472667
P060204, AOR06019
Yes
Aurelie GUIMFACK, Department Clinical Research of Developpement
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Lila BOUADMA, MD Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP