The Optimization of Mycoplasm Pneumonia Antibiotic Therapy: Multi-centre, Prospective, Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- Time to resolution of fever (defined as the period from start of study-drug to relief of fever)
研究概览
简要总结
Mycoplasma pneumoniae, an important pathogen of community acquired pneumonia,are becoming more and more resistant to macrolide. The study aim is to optimize anti-infection therapy.
详细描述
Mycoplasma pneumoniae was one of important atypical pathogens of community acquired pneumonia. As lack of cell wall, β-lactam medicines were invalid, however, macrolides, tetracyclines and quinolones were effective. But from 2001, many countries reported macrolide- resistant Mycoplasma pneumoniae. Typically, erythromycin was first-line antibiotic medicine. With the resistance increasing, Mycoplasm pneumonia treatment will become more and more difficult. Thus, optimization of Mycoplasm pneumonia antibiotic therapy is very important.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed community acquired pneumonia
- •60ys≥age≥18 ys
- •Respiratory symptom (cough accompanied by little or no sputum)
- •New infiltration showed by chest radiology(x-ray or CT)
- •Lung signs was not obvious
- •White blood cell<10,000/mm3
- •Without underlying diseases or mild
排除标准
- •Age<18ys or >60ys
- •Pregnancy or breast-feeding
- •Over one week after the onset of symptoms
- •HIV infection
- •Recent 90-day hospitalized history(length of stay greater than 2 days)
- •Live in nursing homes or rehabilitation hospitals
- •Taken macrolides or quinolones medicines before enrollment
研究组 & 干预措施
Cephalosporins and azithromycin
干预措施: Cephalosporins and azithromycin (Drug)
Moxifloxacin
干预措施: Moxifloxacin (Drug)
结局指标
主要结局
Time to resolution of fever (defined as the period from start of study-drug to relief of fever)
时间窗: one month
usually duration of fever is about one to two weeks
Time to resolution of fever (defined as the period from onset to relief of fever)
时间窗: one month
usually duration of fever is about one to two weeks
次要结局
- Duration of antibiotics(one year)
- Time to resolution of respiratory symptoms(defined as the period from start of study-drug to relief of symptoms)(one year)
- Time to resolution of respiratory symptoms(defined as the period from onset to relief of symptoms)(one year)
- Proportion of antibiotics change(one year)
- Proportion of resolution of fever after antibiotics therapy for 24 hours(one year)
- Proportion of resolution of fever after antibiotics therapy for 72 hours(one year)
- Antibiotic-related adverse reaction(one year)
研究者
Bin Cao
Professor
Capital Medical University