NCT03146182

Biomarker Guided Antibiotic Treatment in Community-Acquired Pneumonia

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: Gertrud Baunbaek Egelund · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 = 0.005/2 = 0.025. 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.

Conditions

• Community Acquired Pneumonia

Interventions

Type	Name	Description
BEHAVIORAL	CRP-algorithm	a strategy based on CRP guided antibiotic stewardship
BEHAVIORAL	PCT-algorithm	a strategy based on PCT guided antibiotic stewardship

Timeline

• Start date: 2017-03-15
• Primary completion: 2018-12-01
• Completion: 2019-02-01
• First posted: 2017-05-09
• Last updated: 2017-05-10

Locations

1 site across 1 country: Denmark