Biomarker Guided Antibiotic Treatment in Community-Acquired Pneumonia
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Duration of antibiotic treatment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Duration of antibiotic treatment
时间窗: 30 days from inclusion
Number of days in antibiotic treatment for pneumonia
次要结局
- Relapse(30 days from inclusion)
- 30 day mortality(30 days from inclusion)
研究者
Gertrud Baunbaek Egelund
M.D.
Nordsjaellands Hospital