Comparative Efficacy of Single-dose Doxycycline Versus Standard 5- Day Amoxicillin Treatment for Patients With Non-malarial Fever: a Randomized Non-inferiority Trial in Senegal
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 274
- 试验地点
- 1
- 主要终点
- Non-inferiority comparison of the efficacy between Doxycycline and Amoxicillin after 7 days of follow-up
研究概览
简要总结
Abstract: Background The current practice in Senegal is to use broad-spectrum antibiotics including amoxicillin and/or cotrimoxazole in case of non-malarial fevers. First-line treatment with doxycycline has cured such patients. The investgators aimed to determine the efficacy of a single dose of doxycycline compared to a 5-day amoxicillin course for the treatment of fever.
详细描述
Methods The investgators conducted a non-inferiority, open-label, randomized controlled trial in patients aged > 8 years recruited from dispensaries in the rural area of Niakhar, Senegal. Participants were enrolled based on a body temperature > 37.5°C, as assessed using an electronic axillary thermometer. Febrile patients with a positive malaria test were excluded from the study. Participants were randomly assigned (1:1) to receive either a single dose of doxycycline (30 mg/kg) or a five-day course of amoxicillin (20 mg/kg) by a computer-generated random number sequence. The investgators monitored participants at days 2 and 7 post-treatment. The primary outcome was cure after 7 days, defined as a body temperature < 37.5°C. The investgators used a non-inferiority margin of 10%. This trial was approved by the national ethic committees of the Senegalese Ministry of Health in May 2017 (0026/MSAS/DPRS/CNERS, March, 7, 2016).
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
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants over 8 years with no malaria fever
排除标准
- •Under 8 years Pregnanants women
研究组 & 干预措施
subjects treated with doxycycline
The participants treated by doxycycline 100 mg will have one dose but followed 5 days
干预措施: Doxycycline (Drug)
subjects treated with amoxycilline
The participants treated with amoxycilline 500 mg will have 2 doses per days during 5 days treatement and follwed during these 5 days
干预措施: Doxycycline (Drug)
subjects treated with amoxycilline
The participants treated with amoxycilline 500 mg will have 2 doses per days during 5 days treatement and follwed during these 5 days
干预措施: Amoxicillin (Drug)
结局指标
主要结局
Non-inferiority comparison of the efficacy between Doxycycline and Amoxicillin after 7 days of follow-up
时间窗: 7 days follow up
The endpoint was cure at day-7 post-inclusion. Clinical cure was defined as a body temperature \< 37.5°C. Clinical failure was defined as persistence of fever \> 37.5°C at day-7. The investgators used a non-inferiority margin of 10%.
次要结局
未报告次要终点
研究者
Aldiouma Diallo
MD
Institut de Recherche pour le Developpement