Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00415753
Status:
COMPLETED
Last Update Posted:
2008-05-23
First Post:
2006-12-22
Brief Title:
Procalcitonin as a Marker of Bacterial Pneumonia
Sponsor:
Aarhus University Hospital Skejby
Organization:
Aarhus University Hospital Skejby
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2008-05
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:
None
Brief Summary:
Objective To evaluate PCT as a marker of bacterial community acquired pneumonia in a Danish Hospital setting To test if it is possible to reduce the use of antibiotics and the length of stay in hospital and the willingness of the clinicians to take this new marker under advisement in their choice of treatment
The study is a randomised controlled intervention study All adult patients admitted to the Department of Infectious Disease at Skejby hospital suspected of a lower respiratory tract infection eg CAP acute exacerbation of COPD and bronchitis are eligible for inclusion Patients are randomised to have either PCT guided treatment or standard care in which case the doctor will not learn the PCT test result In the PCT group the antibiotic treatment will be based on serum PCT as follows If PCT is less than 025 µgL antibiotic treatment is discouraged if PCT is greater than 025 µgL antibiotic treatment is encouraged and if PCT is greater than 05 µgL antibiotic treatment is strongly encouraged The treating doctor is allowed to overrule the treatment guidelines The control group will receive antibiotics according to usual practice
The primary endpoints are antibiotic use and length of stay in hospital Secondary endpoint is the proportion of patients where the treating doctor chooses to disregard the guidelines
The study is a randomised controlled intervention study All adult patients admitted to the Department of Infectious Disease at Skejby hospital suspected of a lower respiratory tract infection eg CAP acute exacerbation of COPD and bronchitis are eligible for inclusion Patients are randomised to have either PCT guided treatment or standard care in which case the doctor will not learn the PCT test result In the PCT group the antibiotic treatment will be based on serum PCT as follows If PCT is less than 025 µgL antibiotic treatment is discouraged if PCT is greater than 025 µgL antibiotic treatment is encouraged and if PCT is greater than 05 µgL antibiotic treatment is strongly encouraged The treating doctor is allowed to overrule the treatment guidelines The control group will receive antibiotics according to usual practice
The primary endpoints are antibiotic use and length of stay in hospital Secondary endpoint is the proportion of patients where the treating doctor chooses to disregard the guidelines
Detailed Description:
None
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