Clinical Trial to Evaluate Intermittent Screening and Treatment and Intermittent Preventive Treatment of Malaria in Asymptomatic Schoolchildren to Decrease P. Falciparum Infection and Transmission
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 746
- 试验地点
- 1
- 主要终点
- P. falciparum gametocyte carriage
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 screening and treatment (IST) - students will receive treatment if they have a positive high sensitivity rapid diagnostic test (RDT). Arm 2: Intermittent preventive treatment (IPT) - all students will receive treatment. Arm 3: Control - students will receive standard of care (no preventive treatment). Outcomes include P. falciparum infection and parasite density, gametocyte carriage and gametocyte density, anemia, cognitive function and educational testing, as well as infection prevalence in student's households to assess the impact on transmission.
详细描述
Students will be enrolled in a single primary school in Machinga District, Malawi. The intervention will be conducted every 6-weeks during the two school terms which coincide with peak malaria transmission. Students in the IPT are and those that test positive in the IST arm will be treatment with dihydroartemisinin-piperaquine (DP) (females less than 10 years old and all males) or chloroquine (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)
- •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 Household members (enrolled in the Household Prevalence survey)
- •Slept in the household for most nights in the last month
- •Age 6 months or older
- •For minors, 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
- •Girls 10 years old and older with epilepsy or 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 Screening and Treatment (IST)
Students will be screened for infection using a higher sensitivity malaria rapid diagnostic test and treated if positive. 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 Screening and Treatment (IST)
Students will be screened for infection using a higher sensitivity malaria rapid diagnostic test and treated if positive. 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 (IPT)
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 (IPT)
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)
结局指标
主要结局
P. falciparum gametocyte carriage
时间窗: 6-8 weeks after the last intervention
detected by q-rtPCR (binary)
P. falciparum infection
时间窗: 6-8 weeks after the last intervention
detected by polymerase chain reaction (PCR, binary)
次要结局
- Number of participant with anemia(6-8 weeks after the last intervention)
- Total parasite density(6-8 weeks after the last intervention)
- Gametocyte density(6-8 weeks after the last intervention)
- Rate of clinical malaria(from the first intervention to 6-8 weeks after the last intervention)
- P. falciparum prevalence among household members(6-8 weeks after the last intervention)
- Mean hemoglobin concentration(6-8 weeks after the last intervention)
研究者
Lauren Cohee
Visiting Assistant Professor
University of Maryland, Baltimore