Evaluation of a Clinical Pathway Based on Procalcitonin Levels for the Management of Community-acquired Pneumonia in Outpatients
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Clinical cure
研究概览
简要总结
A clinical protocol was developed for the management of adult outpatients with community-acquired pneumonia (CAP) and Pneumonia Severity Index risk classes I-II. Patients are assigned to oral azithromycin or levofloxacin according to procalcitonin (PCT) levels measured with a rapid point-of-care method. When PCT levels are <0.5 ng/ml, azithromycin, 500 mg/day is given orally for 5 days; if PCT is ≥0.5 ng/ml, levofloxacin, 500 mg/day is given orally for 7 days
详细描述
A clinical protocol was developed in collaboration with the hospital's Emergency Department for the management of adult outpatients with community-acquired pneumonia (CAP). Patients are assigned to 2 treatment categories according to the plasma procalcitonin (PCT) values.
Treatment assignment:
- PCT<0.5 ng/ml: azithromycin, 500 mg/day orally for 5 days
- PCT≥0.5ng/ml: levofloxacin, 500 mg/day orally for 7 days
Laboratory and microbiological studies:
In the ED, patients with signs and symptoms of pneumonia have a blood sample collected for routine biochemical and hematological determinations, and PCT concentration measurement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Fever with or without respiratory symptoms
- •New infiltrate on chest radiograph
- •Pneumonia Severity Index (PSI) score ≤ 70 (risk classes I and II).
排除标准
- •PSI risk classes III-V
- •Age ≥65 years
- •Comorbidity (diabetes, chronic obstructive pulmonary disease, chronic renal disease, neoplasia, immunosuppression including HIV infection, chronic heart failure or cirrhosis)
- •White blood cell count ≥20.0 x 109/L
- •Pleural effusion
- •Bilateral infiltrates
- •Previous failure or allergy to macrolides or quinolones
- •Need for oxygen therapy -
研究组 & 干预措施
Azithromycin/levofloxacin
Azithromycin or levofloxacin are given according to serum procalcitonin levels
干预措施: Azithromycin (Drug)
Azithromycin/levofloxacin
Azithromycin or levofloxacin are given according to serum procalcitonin levels
干预措施: Levofloxacin (Drug)
结局指标
主要结局
Clinical cure
时间窗: 30-day
Improvement or lack of progression of baseline radiographic findings at the end of therapy and resolution of signs, including chest X-Ray, and symptoms of pneumonia
次要结局
- Number of participants with treatment-related adverse events as assessed by a specific questionnaire designed for the study(30-day)
- Mortality(Through study completion, an average of 3 years)
- Recurrences(Through study completion, an average of 3 years)
研究者
Mar Masiá Canuto
MD
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana