Community Acquired Pneumonia
Conditions
Keywords
C-reactive protein, Procalcitonin, Community-acquired pneumonia, Antibiotic stewardship
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.
Interventions
BEHAVIORALCRP-algorithm
a strategy based on CRP guided antibiotic stewardship
BEHAVIORALPCT-algorithm
a strategy based on PCT guided antibiotic stewardship
Sponsors
Gertrud Baunbaek Egelund
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of antibiotic treatment | 30 days from inclusion | Number of days in antibiotic treatment for pneumonia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 30 day mortality | 30 days from inclusion | Number of patients who die within 30 days. |
| Relapse | 30 days from inclusion | Number of patients who are readmitted due to pneumonia or resumed treatment for pneumonia. |
Countries
Denmark
Contacts
Primary ContactGertrud B Egelund, M.D.
Backup ContactPernille Ravn, M.D.
Outcome results
None listed