Epidemiology of Malaria in Malawi: Human Hosts and Parasites in Three Districts Part 2: Cross-sectional Surveillance (School-based Cohorts)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 786
- 主要终点
- P. falciparum gametocyte density
研究概览
简要总结
A school-based, prospective, cohort study was conducted to evaluate the epidemiology of P. falciparum (Pf) infections in school-age children and determine the impact of the screen-and-treat approach on Pf infection and anemia prevalence among students in two different transmission settings. Investigators aimed to evaluate how frequently malaria rapid diagnostic tests (mRDTs) fail to detect low-parasite-density infections as well as whether low-density infections contribute to the burden and health consequences of Pf infection in school-age children and whether they contain gametocytes, the parasite stage required for transmission from humans to mosquitos.
详细描述
Students were enrolled in four schools in southern Malawi in the rainy (March-May) and dry season (Sept-Nov) of 2015. 15 students per grade-level (grades 1-8), were invited to participate. Following enrollment, students were evaluated at baseline for screening-and-treatment, and followed-up 1, 2 and 6 weeks later. At each follow-up visit, a blood sample was obtained for microscopy and molecular detection of parasites and students were interviewed about bed net use the night prior, current or recent illness, and use of antimalarial treatment. At the final visit, a mRDT and hemoglobin test were repeated, and parents were interviewed and portable medical records ("health passports") were reviewed to identify intercurrent fever or malaria treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Randomly selected student at a participating school
排除标准
- •Parent or guardian not available for consent
- •Age <5 or >= 16 years
- •Known allergy or adverse reaction to lumefantrine-artemether
- •Child will not attend this school during the time of the survey
- •For the dry season survey (Sept-Oct 2015), participants in the rainy season survey (April-May 2015)
结局指标
主要结局
P. falciparum gametocyte density
时间窗: 6 weeks after screening
Pfs25 quantitative reverse transcriptase PCR
P. falciparum infection
时间窗: 6 weeks after screening
Any stage Pf infection detected by quantitative polymerase chain reaction (PCR)
P. falciparum gametocyte presence
时间窗: 6 weeks after screening
Pfs25 quantitative reverse transcriptase PCR
次要结局
- Anemia(6 weeks after screening)
- Microscopic P. falciparum infection(6 weeks after screening)
研究者
Miriam Laufer
Professor
University of Maryland, Baltimore