A Comparative Study of Azithromycin and Sulphadoxine-pyrimethamine as Prophylaxis Against Malaria in Pregnant HIV Positive Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Level of malaria parasitemia at delivery in HIV positive women following administration of Azithromycin or Sulphadoxine- pyrimethamine as intermittent preventive therapy for malaria in pregnancy
研究概览
简要总结
Randomized controlled single blind prospective comparative study
详细描述
This study is intended to be a randomized controlled single blind prospective comparative study conducted to compare the efficacy of three monthly doses of sulphadoxine-pyrimethamine as intermittent preventive therapy for malaria with azithromycin in HIV positive pregnant women
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant HIV positive patients,
- •Gestational age 16 weeks and above,
- •No history of azithromycin or sulphadoxine-pyrimethamine use four weeks prior to recruitment
排除标准
- •Anaemia packed cell volume less than 30%,
- •pre-existing medical conditions- diabetes mellitus,
- •hypertension,
- •allergy to sulphadoxine-pyrimethamine or azithromycin
研究组 & 干预措施
Azithromycin
Tabs Azithromycin 500mg daily for 3 days
干预措施: Sulphadoxine-pyrimethamine (Drug)
Azithromycin
Tabs Azithromycin 500mg daily for 3 days
干预措施: Azithromycin (Drug)
Sulphadoxine-pyrimethamine
500mg of sulphadoxine and 25mg of pyrimethamine 3 tablets every 4 weeks for 3 doses
干预措施: Sulphadoxine-pyrimethamine (Drug)
Sulphadoxine-pyrimethamine
500mg of sulphadoxine and 25mg of pyrimethamine 3 tablets every 4 weeks for 3 doses
干预措施: Azithromycin (Drug)
结局指标
主要结局
Level of malaria parasitemia at delivery in HIV positive women following administration of Azithromycin or Sulphadoxine- pyrimethamine as intermittent preventive therapy for malaria in pregnancy
时间窗: 6 months
次要结局
未报告次要终点
研究者
ORIYOMI OMOTOYOSI AKINYOTU
Senior Registrar
University of Ibadan