Effectiveness of Seasonal Malaria Chemoprevention in Koulikoro, Mali
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 4,556
- 试验地点
- 1
- 主要终点
- Malaria incidence among cohort in 2 years period
研究概览
简要总结
Seasonal Malaria Chemoprevention (SMC) for children less than five years old is one the high impact interventions against malaria in sub-Saharan Africa (SSA). Since 2016, the Government of Mali and partners through the National Malaria Control Program has deployed SMC countrywide during high malaria transmission season with a total of four (4) rounds per year. Sulfadoxine-Pyrimethamine (SP) with Amodiaquine (AQ) are the drugs used for SMC. However, SP is also used for Intermittent preventative treatment (IPTp) for pregnant women while AQ has been used for decades for treatment of uncomplicated malaria.
The proposed study will examine the effect of SMC with Sulfadoxine+Amodiaquine (SP+AQ) extension to older age, the efficacy of Dihydroartemisin-Piperaquine (DHA-PQ) when used for SMC, social, cultural, economic and health systems factors associated with effective implementation of SMC. The specific aims of this study are to: 1] Assess the effect of SMC (SP+AQ) on malaria incidence and infection prevalence in different age groups across sites; 2] Study the effect of SMC (DHA-PQ) compared to SMC (SP-AQ) among children less than 10 years; 3] Determine the cost-effectiveness for each treatment regimen; ) 4] Explore factors determining effective SMC implementation including coverage of children targeted to receive treatment by community distributors, receipt of a full course of treatment, perception of medications by parents and health care providers, and sustainability; and 5) Establish a district based system to identify severe cases.
The expected outcomes of this work, upon completion of our specific aims, include 1) Recommendations to Malian health officials and other partners for improving implementation of SMC and alternative drug to SP+AQ for SMC, and 2) Guidelines for routine monitoring of SMC implementation.
详细描述
Study Aims The primary aim of the proposed research is to compare impact of three different treatment strategies of Seasonal malaria chemoprevention (SMC) on malaria incidence in Koulikoro health district Specific aims: Assess the effect of SMC (Sulfadoxin Pyrimethamin+Amodiaquin) on malaria incidence and infection prevalence in different age groups across sites; Study the effect of SMC with Dihydroartemesinin - Piperaquin compared to SMC with Sulfadoxin Pyrimethamin+Amodiaquin among children less than 10 years; Determine the cost-effectiveness for each treatment regimen; Explore factors determining effective SMC implementation including coverage of children targeted to receive treatment by community distributors, receipt of a full course of treatment, perception of medications by parents and health care providers, and sustainability; and Establish a district-based system to identify severe cases.
Research questions and hypotheses
Primary research question:
-Is SMC extension to children 5-9 years old with Sulfadoxin Pyrimethamin+Amodiaquin more effective on reducing malaria mortality and morbidity during the high malaria transmission season? Null hypothesis (H0): There is no benefit to SMC extension to older children with Sulfadoxin Pyrimethamin+Amodiaquin over standard SMC for children less than 5 years reducing confirmed P. falciparum case incidence, infection incidence, or community parasite prevalence during malaria transmission season
Secondary research questions:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
盲法说明
Any
入排标准
- 年龄范围
- 3 Months 至 119 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Village resident (up to the end of the malaria transmission season)
- •Age 3 months to 119 month age at the time of enrollment
- •Parent or guardian provided consent for their child's participant (5-14 years old)
- •Absence of chronic diseases, history of allergy to SP, AQ or DHA-PQ
排除标准
- •Non resident
- •Age less than 3months or greater or equal to 119 months at the time of cohort enrollment
- •Presence of chronic diseases, history of allergy to SP, AQ or DHA-PQ
- •Does not provide consent/assent required according to age to participate in the study
研究组 & 干预措施
Standard
The Mali National Malaria Control program has initiated SMC for children less than 5 years since 2016 (countrywide) with SPAQ. This standard care will not change in this arm
干预措施: Sulfadoxine pyrimethamine + Amodiaquin (Drug)
SMC with SPAQ extended to older children
Within this arm, SMC with SPAQ will be extended to children 5-9 years old
干预措施: Sulfadoxine pyrimethamine + Amodiaquin (Drug)
SMC with DHAPQ
Children less than 10 years within this arm will received Dihydroartemisin piperaquin for SMC instead of SPAQ
干预措施: Dihydroartemisinin piperaquin (Drug)
结局指标
主要结局
Malaria incidence among cohort in 2 years period
时间窗: 2 years
The incidence of malaria (uncomplicated or severe malaria): Uncomplicated malaria being defined as symptomatic malaria parasitaemia with no signs of severity and/or evidence of vital organ dysfunction measured by: (1) rapid diagnostic tests and/or (2) microscopy of blood smears. Severe malaria is defined as confirmed malaria parasitemia plus fever or history of fever (at least 37°C) plus evidence of severe/complicated pathology; e.g., convulsions, vomiting, coma, rapid (kussumal) breathing or evidence of vital organ dysfunction, and severe anemia.
次要结局
- Drug resistance marker prevalence in two 2 years period(1 year)
- Malaria infection prevalence at the start and the end of malaria transmission season(2 years)
- SMC coverage and treatment compliance during malaria transmission season(2 years)