Open labelled randomized controlled trial on efficacy of azithromycin versus doxycycline inpediatric scrub typhus.
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Our primary outcome shall be the proportion of children achieving defervescence within 5 days of starting DX or AZ. Defervescence is defined as the interval between the time at which first dose of antibiotic is administered  and the time at which the axillary temperature falls below 37.8˚C and is maintained for 48 hours without antipyretics.
研究概览
简要总结
In a PRISMA - compliant systematic review and meta- analysis, it was concluded that azithromycin is as effective as other anti-rickettsial drugs with higher treatment success rates, lower adverse effects, and longer time to defervescence14. However, all these studies were done on adult population. Recent Cochrane review tried to find out whether certain antibiotics are more effective in treating scrub typhus19. For specific outcomes, low certainity evidence suggests that there may be little or no difference between tetracycline, doxycycline and azithromycin19. Thus, there is limited but promising data regarding efficacy and optimal dosage of azithromycin for treatment of scrub typhus especially in children. Hence, we planned this study to compare the efficacy of azithromycin with doxycycline in children suffering from scrub typhus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 1.00 Year(s) 至 14.00 Year(s)（—）
- 性别
- All
入选标准
- •Children admitted in the hospital will be eligible for enrollment if they fulfill the following inclusion criteria: Children 6 months to 18 years suffering from acute febrile illness of 5 days or more and scrub typhus IgM serology positive by ELISA (cutoff optical density 0.5 or more).
排除标准
- •Patients will be excluded from study if : 1.History of hypersensitivity to macrolides or tetracylines. 2.Indications of presence of a febrile illness unrelated to scrub typhus. 3.Patients who had ingested any agents with potential antirickettsial activity (e.g., rifampicin, chloramphenicol, macrolides, or tetracycline) within 48 hours prior to randomization.
- •4.Patient with heart disease.
- •5.Post randomization scrub IgM serology negative in case of critically sick patients who are randomized awaiting scrub serology.
结局指标
主要结局
Our primary outcome shall be the proportion of children achieving defervescence within 5 days of starting DX or AZ. Defervescence is defined as the interval between the time at which first dose of antibiotic is administered  and the time at which the axillary temperature falls below 37.8˚C and is maintained for 48 hours without antipyretics.
时间窗: defervescence within 5 days of starting DX or AZ.
次要结局
- Additionally participants will be assessed for hospitalization duration, time to defervescence, need for ventilation, inotropic support, blood transfusion, renal replacement therapy and any adverse event.