The purpose of this study is to evaluate two different treatment strategies in patients admitted to hospital with Community Acquired Pneumonia. The investigators hypothesize treatment according to both procalcitonin (PCT) and C-reactive protein (CRP) will be effective in reducing the length of antibiotic treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
468
The cutoff point is a CRP below 100 mg/L and a reduction to 50% of the initial value.
The cutoff point is a PCT below 0.25 mcg/L or a reduction to 10% of the initial value.
Often a 7 days course of antibiotics, treatment may be extended if the attending physician deems it necessary.
Medical Centre Alkmaar
Alkmaar, North Holland, Netherlands
Slotervaart Hospital
Amsterdam, North Holland, Netherlands
ISALA clinics
Zwolle, Overijssel, Netherlands
Length of antibiotic treatment
Time frame: End of the study
Length of stay
Time frame: End of the study
Clinical response
Cure - resolution or improvement of symptoms and clinical signs related to pneumonia without the need for additional or alternative antibiotic therapy Failure - persistence or progression of all signs and symptoms of the acute process after randomisation or the development of a new pulmonary or extrapulmonary respiratory tract infection, or the progression of abnormalities on chest radiograph after randomisation, or death due to pneumonia, or the inability to complete the study owing to adverse events Indeterminate - patient receives less than 80% of the study drug for reasons other than clinical failure, a concomitant infection outside the respiratory tract requiring antibiotic treatment, lost to follow-up, or death unrelated to the primary diagnosis.
Time frame: End of the study
30-day mortality
All cause
Time frame: End of the study, periodically by the DSMB
Time to clinical stability
Patients are considered clinically stable if they fulfill all of these criteria: Temperature equal to or below 37.8 degrees celsius, heart rate equal to or below 100 beats per minute, respiratory rate equal to or below 24 breaths per minute, systolic blood pressure equal to or above 90 mmHg, arterial oxygen saturation equal to or above 90 percent or pO2 equal to or above 60 mmHg on room air, ability to maintain oral intake, normal mental status.
Time frame: End of the study
Relapse rate
Time frame: End of the study
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