NCT00472667

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
630

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2007

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2007

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 14, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

November 25, 2008

Status Verified

May 1, 2007

Enrollment Period

10 months

First QC Date

May 11, 2007

Last Update Submit

November 24, 2008

Conditions

Bacterial Infections

Keywords

Bacterial infectionsProcalcitoninIntensive care unitAntibiotic therapySuspicion of bacterial infection or proven

Outcome Measures

Primary Outcomes (2)

  • Exposition to antibiotics, defined by antibiotic-free days

    assessed 28 days after inclusion

  • Mortality

    at Day 28 and Day 60

Secondary Outcomes (7)

  • 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

  • +2 more secondary outcomes

Study Arms (1)

1

EXPERIMENTAL

Procalcitonin guided strategy

Procedure: Procalcitonin guided strategy

Interventions

Procalcitonin guided strategyPROCEDURE

Procalcitonin guided strategy

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient hospitalised in the ICU
  • Bacterial infection suspected
  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Bichat Claude Bernard

Paris, 75018, France

Location

Related Publications (1)

  • 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.

    PMID: 20097417DERIVED

MeSH Terms

Conditions

Bacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Study Officials

  • Lila BOUADMA, MD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 11, 2007

First Posted

May 14, 2007

Study Start

July 1, 2007

Primary Completion

May 1, 2008

Study Completion

May 1, 2008

Last Updated

November 25, 2008

Record last verified: 2007-05

Locations

FR(1)