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临床试验/NCT03911440
NCT03911440Unknown不适用

Diagnosis and Treatment of Mycoplasma Pneumoniae and Vaccine Development

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年11月10日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Defervescence

研究概览

简要总结

A randomized clinical trial comparing treatment effectiveness of azithromycin and doxycycline for pediatric Mycoplasma pneumonia.

详细描述

Mycoplasma pneumoniae accounts for 10-30% of community-acquired pneumonia (CAP) in children. Proportionally, M. pneumoniae has become the most important pathogen for childhood pneumonia after the widespread use of Streptococcus pneumoniae vaccines. M. pneumoniae is routinely treated with antibiotics, and the macrolides antibiotics are the drug of choice for M. pneumonia infection. However, macrolide-resistance rates have increased to 20 and 100% in Asia. In previous studies, the most common mutation point, A2063G, was detected from 23% of local strains in Taiwan. The evolution and spreading of Mycoplasma in Taiwan and different countries are unknown. While the macrolide-resistance is increasing, the optimal therapy remains unclear. Both tetracyclines and fluoroquinolones showed promises in treating macrolide-resistant M. pneumoniae in adults. However, their use in children is not recommended due to safety concerns. Recently, evidence are accumulating that doxycycline, unlike other tetracyclines, does not cause staining of teeth. In the current study, the investigators are going to carry out a randomized control trial to compare the efficacy and safety of doxycycline against macrolide-resistant M. pneumoniae.

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
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Children aged 0-18 years, admitted due to lower respiratory tract infections. Mycoplamsa pneumonia is diagnosed.
  • The diagnosis is made within 72 hours after fever onset.
  • The patient and his/her guardians are willing to participate the study and able to follow the instruction.

排除标准

  • 未提供

研究组 & 干预措施

Azithromycin

Active Comparator

Azithromycin (10mg/kg/day) is given to children with mycoplasma pneumonia for 3 days.

干预措施: Azithromycin (Drug)

Doxycycline

Experimental

Doxycycline (2-4mg/kg/day) is given to children with mycoplasma pneumonia for 5-10 days.

干预措施: Doxycycline (Drug)

结局指标

主要结局

Defervescence

时间窗: Up to 10 days

The timing (days) when fever subsides after treatment

次要结局

  • Hospital stay(Up to 2 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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