The Impact of Intermittent Malaria Treatment Administered Through the EPI Scheme on Malaria Morbidity in Mozambican Children
试验速览
- 阶段
- 1 期
- 入组人数
- 1,498
- 试验地点
- 1
- 主要终点
- Incidence of first or only malaria episodes in each study cohort by 12 months of age.
研究概览
简要总结
To evaluate if intermittent preventive treatment in infants (IPTi) consisting of SP [Fansidar] given through the EPI scheme alongside routine immunisations at 3, 4 and 9 months of age reduces de incidence of clinical malaria up to 12 months of age
详细描述
The study is a randomised, double blind, placebo-controlled trial of the antimalarial drug sulphadoxine-pyrimethamine administered intermittently at 3, 4 and 9 months of age through the EPI scheme at the time of routine immunisations.
Children will be randomized into placebo and SP treatment groups by block randomization, and it is expected a similar age distribution and a similar number of children in each group.
Doses of sulphadoxine (25 mg/kg)-pyrimethamine (1.25 mg/kg) (SP) or placebo will be given by a health assistant according to bodyweight (a quarter of a tablet for those <5kg, a half for those 5-10 kg, and a whole tablet for children >10 kg). The tablets will be crashed and diluted with water for their administration.
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
- Double
入排标准
- 年龄范围
- — 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children from study area
- •Signed informed consent
排除标准
- •History of drug allergies
结局指标
主要结局
Incidence of first or only malaria episodes in each study cohort by 12 months of age.
次要结局
- Incidence of multiple malaria episodes up to 12 months of age.
- Incidence of multiple malaria episodes up to 24 months of age.
- Incidence of side effects in each group up to 12 months of age.
- Incidence of overall and severe anaemia up to 12 months of age.
- Prevalence of P falciparum parasitaemia and overall and severe anaemia at 12 months of age.
- Proportion of humoral and cellular immune responses against malaria at 12 months of age.
- Total number of admissions and outpatient attendances up to 24 months of age.
- Proportion of humoral responses and geometric mean antibody titres of polio, DTP and Hepatitis B at 5 months and of measles at 9 and 12 months
- Incidence of first or only malaria episodes by group up to 12 months of age as per protocol analysis.
- Incidence of first or only malaria episodes by group up to 24 months of age.
- Incidence of overall and severe anaemia up to 24 months of age.