Community Acquired Pneumonia Clinical Trial
Official title:
Biomarker Guided Antibiotic Treatment in Community-Acquired Pneumonia
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.
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.
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