Feasibility and Effectiveness of Delivering Mass Drug Administration for Helminths Through the Seasonal Malaria Chemoprevention (SMC) Platform in a West African Paediatric Population
试验速览
- 阶段
- 不适用
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Incidence of Treatment-Emergent Adverse Events
研究概览
简要总结
Malaria remains a major health problem, especially in sub-Saharan Africa where more than 90% of the disease and deaths occur in children. Adding to this high burden among the children is the co-existence of intestinal and genito-urinary worms. Prominent among these are soil-transmitted helminths and schistosomiasis. Existing control programmes for the worms are operating below the expected level, despite the commitments and support that followed the 2012 London Declaration of achieving 75% treatment coverage by 2020. On the other hand, a malaria prevention programme, called Seasonal Malaria Chemoprevention (SMC), introduced in the same year 2012 has achieved more than 75% treatment coverage and prevented 75-85% cases of uncomplicated and severe malaria in children. This encouraging development supports the need to explore the strategies involving the integration of worm control with successful platforms such as SMC. This would align worm and malaria control with the WHO road map for Neglected Tropical Diseases (NTD) of ending the neglect to attain Sustainable Development Goals by eradicating diseases of poverty and promoting health and well-being for those at risk. Given this context, it is important to develop a treatment approach that combines malaria and helminth control in an integrated framework that will be safe, effective and easy to deliver. This study will, therefore, investigate the feasibility and effectiveness of co-administration of anthelminthic and SMC drugs in a high-risk paediatric population living in a malaria-helminth co-endemic setting in Senegal, West Africa. This study is designed to test the hypothesis that co-administration of SMC and anthelminthic drugs will be safe and tolerated among children aged 1-14 years and that the incidence of side effects will not be significant. The objectives of this study are to assess the safety, tolerability, and effects of co-administration of SMC and anthelminthic drugs among the children
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
- 1 Year 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female children aged 1-14 years;
- •Provision of a written informed consent by the parent/caregiver and a positive assent by children aged ≥ 12 years (in line with legal regulations in Senegal);
- •Willingness to provide finger-prick blood samples, urine, and stool samples;
- •Residence in the study area for at least six months
排除标准
- •Acutely ill child at the time of the drug administration;
- •Child whose parents/caregivers decline to provide consent;
- •A known HIV positive child receiving cotrimoxazole prophylaxis;
- •A child who has received a dose of any of sulphadoxine-pyrimethamine, amodiaquine, albendazole or praziquantel during the previous six months;
- •A child with a known allergy to any of sulphadoxine-pyrimethamine, amodiaquine, albendazole or praziquantel.
研究组 & 干预措施
Praziquantel + Vitamin A on Day 0, followed SMC course on Days 1,2 & 3
干预措施: Amodiaquine (Drug)
Praziquantel + Vitamin A on Day 0, followed SMC course on Days 1,2 & 3
干预措施: Sulfadoxine pyrimethamine (Drug)
Vitamin A + Zinc supplements on Day 0, followed by SMC course on Day 1,2 & 3
干预措施: Amodiaquine (Drug)
Vitamin A + Zinc supplements on Day 0, followed by SMC course on Day 1,2 & 3
干预措施: Sulfadoxine pyrimethamine (Drug)
Praziquantel + Vitamin A on Day 0, followed SMC course on Days 1,2 & 3
干预措施: Praziquantel (Drug)
Albendazole + Praziquantel on Day 0, followed by SMC course on Days 1, 2 & 3
干预措施: Albendazole (Drug)
Albendazole + Praziquantel on Day 0, followed by SMC course on Days 1, 2 & 3
干预措施: Praziquantel (Drug)
Albendazole + Praziquantel on Day 0, followed by SMC course on Days 1, 2 & 3
干预措施: Amodiaquine (Drug)
Albendazole + Praziquantel on Day 0, followed by SMC course on Days 1, 2 & 3
干预措施: Sulfadoxine pyrimethamine (Drug)
结局指标
主要结局
Incidence of Treatment-Emergent Adverse Events
时间窗: For six consecutive days after start of the drug administration
Incidence of Treatment-Emergent Adverse Events will be measured by collecting solicited and unsolicited adverse events and adverse drug reactions for causal relationships to the study drugs.
次要结局
- Prevalence of Schistosoma co-infection(On the day of randomisation (pre-intervention) and up to 4 months post-intervention)
- Prevalence of helminth co-infection(On the day of randomisation (pre-intervention) and up to 4 months post-intervention)
- Prevalence of intensity of helminth infection(On the day of randomisation (pre-intervention) and up to 4 months post-intervention)