A Trial of Seasonal Malaria Chemoprevention Plus Azithromycin in African Children
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 22,090
- 试验地点
- 2
- 主要终点
- severe morbidity and mortality
研究概览
简要总结
The primary objective of this study is to determine whether addition of azithromycin (AZ) to Seasonal Malaria Chemoprevention (SMC) using sulphadoxine/pyrimethamine (SP) +amodiaquine (AQ) will provide an additional reduction in deaths and severe illness in young African children. The secondary objectives include an assessment of the safety and cost-effectiveness of the addition of AZ to SMC with SP+AQ.
This a double blind, randomised, placebo controlled trial. The unit of randomisation will be the household. Children aged 3 - 59 months will be randomised to receive four cycles of either SP+AQ+AZ or SP+AQ+ placebo at monthly intervals during the peak malaria transmission season.
Study Sites: Hounde district in Burkina Faso and in Bougouni district, Mali. Children of 3-59 months of age at the start of each period of drug administration will be eligible for inclusion in the trial provided that parental consent is obtained. Children with a severe, chronic illness or known allergy to one of the study drugs will be excluded.
Primary endpoint: Incidence of the combination of death or hospital admission for at least 24 hours, not due to trauma or elective surgery during the intervention period
Secondary endpoints:
- incidence of the primary endpoint during the whole study period
- attendance at a study health centre with a nonmalaria febrile illness
- attendance at a study health centre with malaria,
- the prevalence of moderate anaemia at the end of each malaria transmission season,
- nutritional status at the end of each malaria transmission season,
- prevalence of nasopharyngeal carriage with pneumococci and macrolide resistant pneumococci before and at the end of each malaria transmissions season,
- prevalence of resistance markers to SP at the end of the study,
Sample size: 19,200 children (9600 in each country) will be enrolled.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Months 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children of either sex aged 3-59 months of age at the start of each period of drug administration
- •parental consent is obtained.
排除标准
- •a severe, chronic illness,
- •a known allergy to one of the study drugs.
- •HIV+ children on cotrimoxazole prophylaxis
研究组 & 干预措施
Seasonal malaria chemoprevention
Sulphadoxine-Pyrimethamine Amodiaquine Placebo Azithromycin
干预措施: Sulphadoxine-pyrimethamine + amodiaquine + placebo azithromycin (Drug)
seasonal malaria chemoprevention plus AZ
Sulphadoxine-Pyrimethamine+ Amodiaquine + Azithromycin 4 rounds during malaria transmission season
干预措施: Sulphadoxine-Pyrimethamine+ Amodiaquine+ Azithromycin (Drug)
结局指标
主要结局
severe morbidity and mortality
时间窗: from the time of enrolment upto the end of malaria transmission in year 3 ( the person time at risk will be restricted to three malaria transmission seasons)
Incidence of the combination of death or hospital admission for at least 24 hours, not due to trauma or elective surgery during the intervention period.
次要结局
- macrolide resistant pneumococci carriage(before administration of first dose of SMC and at the end of malaria transmission season in year 1, 2 and 3,)