Clinical Trial to Evaluate Intermittent Screening and Treatment and Intermittent Preventive Treatment of Malaria in Asymptomatic Schoolchildren to Decrease P. Falciparum Infection and Transmission: Phase 2 Comparing Drug Regimens
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 646
- 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 chloroquine (CQ) (IPT-SPCQ). 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 in young children sleeping student's households to assess the impact on transmission.
详细描述
Students attending a single primary school in Machinga District, Malawi who were enrolled in NCT05244954 were offered enrollment in this follow-on study. The intervention will be conducted every 6-weeks during the two 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 10 years old and all males) or chloroquine (females 10 years old or older. Students in the IPT-SPCQ arm will be treated with sulfadoxine-pyrimethamine plus chloroquine (females less than 10 years old and all males) or chloroquine alone (females 10 years old or older).
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)
盲法说明
Laboratory technicians processing samples will be blinded to participant's study arm.
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
- •Students (enrolled in the primary intervention)
- •Previously enrolled in NCT05244954
- •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 Younger children in participant households (enrolled in the Household Prevalence survey)
- •Slept in the household for most nights in the last month
- •Age 6-59 months
- •Parent/guardian available to provide written informed consent
排除标准
- •Students (enrolled in the primary intervention)
- •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
- •Taking trimethoprim-sulfamethoxazole aka Bactrim or Cotrimoxazole
- •Psoriasis Household members (enrolled in the Household Prevalence survey)
- •Household with more than one school-age child enrolled in the study
- •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 10 years old and all males) or chloroquine (females 10 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 10 years old and all males) or chloroquine (females 10 years old or older).
干预措施: Chloroquine (Drug)
Intermittent Preventive Treatment with sulfadoxine-pyrimethamine plus chloroquine (IPT-SPCQ)
All students are treated at each intervention. Treatment will be with SP + CQ (females less than 10 years old and all males) or chloroquine (females 10 years old or older).
干预措施: Chloroquine (Drug)
Intermittent Preventive Treatment with sulfadoxine-pyrimethamine plus chloroquine (IPT-SPCQ)
All students are treated at each intervention. Treatment will be with SP + CQ (females less than 10 years old and all males) or chloroquine (females 10 years old or older).
干预措施: Sulfadoxine pyrimethamine (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)
次要结局
- Math skills(6-8 weeks after the last intervention)
- Total parasite density(6-8 weeks after the last intervention)
- Rate of clinical malaria(through study completions, 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)
- sustained attention(6-8 weeks after the last intervention)
- Number of participants with anemia(6-8 weeks after the last intervention)
- Mean hemoglobin concentration(6-8 weeks after the last intervention)
- selective attention(6-8 weeks after the last intervention)
- Literacy skills(6-8 weeks after the last intervention)
研究者
Lauren Cohee
Assistant Professor of Pediatrics
University of Maryland, Baltimore