COPD Clinical Trial
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 (e.g. 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 0.25 µg/L antibiotic treatment is
discouraged; if PCT is greater than 0.25 µg/L antibiotic treatment is encouraged and if PCT
is greater than 0.5 µg/L 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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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