Ignite Creation Date:
2024-05-05 @ 5:12 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00407147
Status:
TERMINATED
Last Update Posted:
2012-01-18
First Post:
2006-11-29
Brief Title:
Procalcitonin Level to Discontinue Antibiotics on ICU Patients With no Obvious Site of Infection
Sponsor:
Brahms AG
Organization:
Brahms AG
Study Overview
Official Title:
ProBac - Use of Procalcitonin Level as Part of a Decision Tree to Discontinue Antibiotics When Started Empirically in the ICU in Hemodynamically Stable Patients With no Site of Infection Identified
Status:
TERMINATED
Status Verified Date:
2012-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
termination due to futility very slow patient enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to test whether a US Food and Drug Administration FDA approved laboratory test PCT Kryptor can help doctors make better decisions on the need for antibiotic therapy in ICU patients with suspected infections
Detailed Description:
The study is undertaken as prospective randomized controlled multicenter trial The study population ICU patients with empiric antibiotic treatment due to suspected but unproven infection is randomly assigned to either a Standard Care Group or a Procalcitonin PCT Guided Group In the standard care group antibiotic treatment would be based totally on clinical decision making with traditional thought processes ie cultures response to antibiotics risk of untreated infection other laboratory findings etc The PCT guided group will use the same traditional thought processes and in addition the physician will be given access to a PCT value for Day 1 and Day 4 along with the recommended thresholds for likelihood of infection In conjunction with other laboratory findings and clinical assessments the threshold of PCT is used to continue or discontinue empiric antibiotic treatment
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