Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00472667
Status:
COMPLETED
Last Update Posted:
2008-11-25
First Post:
2007-05-11
Brief Title:
PROcalcitonin Reduce Antibiotic Treatments in Acute-Ill Patients PRORATA
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Impact of Procalcitonin to Reduce Antibiotics Use in ICU Adults Patients
Status:
COMPLETED
Status Verified Date:
2007-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PRORATA
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| AOR06019 | None | None | None |