Status:
COMPLETED
PROcalcitonin Reduce Antibiotic Treatments in Acute-Ill Patients (PRORATA)
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Bacterial Infections
Eligibility:
All Genders
18+ years
Phase:
NA
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 ...
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 antibioti...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
630 Patients enrolled
Trial Details
Trial ID
NCT00472667
Start Date
July 1 2007
End Date
May 1 2008
Last Update
November 25 2008
Active Locations (1)
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1
Chu Bichat Claude Bernard
Paris, France, 75018