Preventing Malaria in School Children to Protect the Whole Community in Rural Blantyre District, Malawi
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 788
- 试验地点
- 1
- 主要终点
- Number of participants with P. falciparum infection
研究概览
简要总结
This is an individually randomized, controlled, single blind three arm clinical trial of malaria chemoprevention strategies Arm 1: Intermittent preventive treatment with dihydroartemisinin-piperaquine (IPT-DP). Arm 2: Intermittent preventive treatment with sulfadoxine-pyrimethamine (SP) plus amodiaquine (AQ) (IPT-SPAQ). Arm 3: Control - students will receive standard of care (no preventive treatment). Outcomes include P. falciparum infection and parasite density, anemia, cognitive function and educational testing, as well as infection prevalence and disease incidence in young children sleeping student's households to assess the impact on transmission.
详细描述
Students attending primary school in rural Blantyre District, Malawi will be offered enrollment in this study. The intervention will be conducted every 6-weeks during the school terms which coincide with peak malaria transmission. Students in the IPT-DP arm will be treated with with dihydroartemisinin-piperaquine (DP) (females less than 13 years old and all males) or chloroquine (females 13 years old or older). Students in the IPT-SPAQ arm will be treated with sulfadoxine-pyrimethamine plus amodiaquine (females less than 13 years old and all males) or chloroquine alone (females 13 years old or older). Students in the all arms will receive routine malaria education.
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
- 6 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Student Inclusion Criteria:
- •Currently enrolled in the study school
- •Plan to attend the study school for the remainder of the school year
- •Parent/guardian available to provide written informed consent
排除标准
- •Current evidence of severe malaria or danger signs
- •Known adverse reaction to the study drugs
- •History of cardiac problems or fainting
- •Taking medications known to prolong QT
- •Family history of prolonged QT
- •History of epilepsy or psoriasis
- •Taking cotrimoxazole for long-term prophylaxis
- •Younger child Inclusion Criteria
- •Slept in the household for most nights in the last month
- •Age 6-59 months
- •Parent/guardian available to provide written informed consent
- •Younger child Exclusion Criteria
- •- Current evidence of severe malaria or danger signs
研究组 & 干预措施
Intermittent Preventive Treatment with dihydroartemisinin-piperaquine (IPT-DP)
All students are treated at each intervention. Treatment will be with DP (females less than 13 years old and all males) or chloroquine (females 13 years old or older).
干预措施: Dihydroartemisinin-Piperaquine (Drug)
Intermittent Preventive Treatment with dihydroartemisinin-piperaquine (IPT-DP)
All students are treated at each intervention. Treatment will be with DP (females less than 13 years old and all males) or chloroquine (females 13 years old or older).
干预措施: Chloroquine (Drug)
Intermittent Preventive Treatment with sulfadoxine-pyrimethamine plus amodiaquine (IPT-SPAQ)
All students are treated at each intervention. Treatment will be with SP and AQ (females less than 13 years old and all males) or chloroquine (females 13 years old or older).
干预措施: Chloroquine (Drug)
Intermittent Preventive Treatment with sulfadoxine-pyrimethamine plus amodiaquine (IPT-SPAQ)
All students are treated at each intervention. Treatment will be with SP and AQ (females less than 13 years old and all males) or chloroquine (females 13 years old or older).
干预措施: Sulfadoxine-pyrimethamine-amodiaquine (Drug)
结局指标
主要结局
Number of participants with P. falciparum infection
时间窗: 6-8 weeks after the last intervention
detected by polymerase chain reaction (PCR, binary)
Number of participants with anemia
时间窗: 6-8 weeks after the last intervention
World Health Organization age-sex definitions (binary)
Rate of clinical malaria
时间窗: through study completion (approximately 6 months), and 6 months following the intervention
cumulative incidence
次要结局
- Mean hemoglobin concentration(6-8 weeks after the last intervention)
- Literacy skills(6-8 weeks after the last intervention)
- Math skills(6-8 weeks after the last intervention)
- Rate of school absenteeism among participants(through study completion (approximately 6 months))
- P. falciparum prevalence among children less than 5 years old living in households with study participants(6-8 weeks after the last intervention)
- Rate of clinical malaria among children less than 5 years old living in households with study participants(through study completion (approximately 6 months))