Biomarker Guided Antibiotic Treatment in Community-Acquired Pneumonia
- Conditions
- Community Acquired Pneumonia
- Interventions
- Behavioral: PCT-algorithmBehavioral: CRP-algorithm
- Registration Number
- NCT03146182
- Lead Sponsor
- Gertrud Baunbaek Egelund
- 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 = 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 300
- Patients 18 years of age or older admitted to hospital with community acquired pneumonia defined as a new infiltrate on x-ray and at least one of the following; cough, expectoration, dyspnea, fever and pathological lung-auscultation.
- Not admitted to hospital within the last 14 days
- The patients has been prescribed antibiotic treatment for pneumonia
- The patient can comprehend the written and verbal information and has provided written consent.
- Patient are unable to give written consent or patient does not understand the Danish language.
- Active pulmonary tuberculosis
- Severe immunosuppression determined by the treating physician (i.e. treatment with highdose corticosteroid for more than 2 weeks, chemotherapy and neutropenia with neutrophils < 0.5x109/l, ongoing treatment with biological drugs, chronic HIV-infection with CD4 cell count < 350 mio./l, immunosuppression after organ transplantation).
- Pregnancy and breastfeeding
- Patients admitted to hospital and treated against their will.
- Terminal ill patients where active treatment is stopped within the first 48 hours of admission.
- Patients who are, from the date of inclusion, prescribed antibiotic treatment for more than 3 days on a different indication than pneumonia.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PCT PCT-algorithm Patients are treated according to the PCT-algorithm. PCT is measured daily. Antibiotic treatment is stopped when PCT reach threshold value. CRP CRP-algorithm Patients are treated according to the CRP-algorithm. CRP is measured daily. Antibiotic treatment is stopped when CRP reach threshold value.
- Primary Outcome Measures
Name Time Method Duration of antibiotic treatment 30 days from inclusion Number of days in antibiotic treatment for pneumonia
- Secondary Outcome Measures
Name Time Method Relapse 30 days from inclusion Number of patients who are readmitted due to pneumonia or resumed treatment for pneumonia.
30 day mortality 30 days from inclusion Number of patients who die within 30 days.
Trial Locations
- Locations (1)
Nordsjællands Hospital.
🇩🇰Hillerød, Denmark