Ignite Creation Date:
2024-05-06 @ 10:02 AM
Last Modification Date:
2024-10-26 @ 12:23 PM
Study NCT ID:
NCT03146182
Status:
UNKNOWN
Last Update Posted:
2017-05-10
First Post:
2017-05-05
Brief Title:
Biomarker Guided Antibiotic Treatment in Community-Acquired Pneumonia
Sponsor:
Gertrud Baunbaek Egelund
Organization:
Nordsjaellands Hospital
Study Overview
Official Title:
Biomarker Guided Antibiotic Treatment in Community-Acquired Pneumonia
Status:
UNKNOWN
Status Verified Date:
2017-05
Last Known Status:
RECRUITING
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:
BIO-CAP
Brief Summary:
The purpose of this study is to determine the efficacy of C-reactive protein and procalcitonin based guidelines versus standard of care to reduce duration of antibiotic exposure in patients hospitalized with community acquired pneumonia
Detailed Description:
BIO-CAP is a prospective randomized intervention study which aims to evaluate the efficacy of C-reactive protein CRP based guidelines and procalcitonin PCT based guidelines to reduce duration of antibiotic exposure in adult patients hospitalized with community-acquired pneumonia CAP compared to standard-of-care
Hypothesis the duration of antibiotic exposure can be reduced when a biomarker algorithm - in addition to standard of care - is used to stop antibiotic treatment
1 CRP based guidelines can reduce duration of antibiotic exposure equally to procalcitonin based guidelines and 2 Either of these two biomarker algorithms CRP or PCT are superior compared to standard of care
Sample size Preconditions significance level α 5 and power β 80 Test unpaired T-test Mean treatment time 11 days SD 5 in this population Relevant detection limit defined at 2 days The bonferroni correction has been used to correct for the fact that 2 primary analysis will be performed why α 00052 0025 Estimated 100 patient in each arm thus n 300
Site monitoring and auditing The study is monitored by the unit for Good Clinical Practice Bispebjerg Hospital Denmark
Hypothesis the duration of antibiotic exposure can be reduced when a biomarker algorithm - in addition to standard of care - is used to stop antibiotic treatment
1 CRP based guidelines can reduce duration of antibiotic exposure equally to procalcitonin based guidelines and 2 Either of these two biomarker algorithms CRP or PCT are superior compared to standard of care
Sample size Preconditions significance level α 5 and power β 80 Test unpaired T-test Mean treatment time 11 days SD 5 in this population Relevant detection limit defined at 2 days The bonferroni correction has been used to correct for the fact that 2 primary analysis will be performed why α 00052 0025 Estimated 100 patient in each arm thus n 300
Site monitoring and auditing The study is monitored by the unit for Good Clinical Practice Bispebjerg Hospital Denmark
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 2015-002501-11 | EUDRACT_NUMBER | None | None |