BIO-CAP: Biomarker Guided Antibiotic Treatment in Community-Acquired Pneumonia
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
- 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Control Patients are treated according to current local guidelines on antibiotic treatment for CAP. |
|
| Experimental: CRP Patients are treated according to the CRP-algorithm. CRP is measured daily. Antibiotic treatment is stopped when CRP reach threshold value. |
Behavioral: CRP-algorithm
a strategy based on CRP guided antibiotic stewardship
|
| Experimental: PCT Patients are treated according to the PCT-algorithm. PCT is measured daily. Antibiotic treatment is stopped when PCT reach threshold value. |
Behavioral: PCT-algorithm
a strategy based on PCT guided antibiotic stewardship
|
Outcome Measures
Primary Outcome Measures
- Duration of antibiotic treatment [30 days from inclusion]
Number of days in antibiotic treatment for pneumonia
Secondary Outcome Measures
- 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.
Eligibility Criteria
Criteria
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.
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Not admitted to hospital within the last 14 days
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The patients has been prescribed antibiotic treatment for pneumonia
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The patient can comprehend the written and verbal information and has provided written consent.
Exclusion Criteria:
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Patient are unable to give written consent or patient does not understand the Danish language.
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Active pulmonary tuberculosis
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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).
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Pregnancy and breastfeeding
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Patients admitted to hospital and treated against their will.
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Terminal ill patients where active treatment is stopped within the first 48 hours of admission.
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Patients who are, from the date of inclusion, prescribed antibiotic treatment for more than 3 days on a different indication than pneumonia.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Nordsjællands Hospital. | Hillerød | Denmark | 3400 |
Sponsors and Collaborators
- Gertrud Baunbaek Egelund
Investigators
- Principal Investigator: Gertrud B Egelund, M.D., Department of pulmonary and infectious diseases, Nordsjaellands Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BIO-CAP_NZH
- 2015-002501-11