Child Health and Infection With Low Density (CHILD) Malaria, a Randomized Controlled Trial to Assess the Long-term Health and Socioeconomic Impact of Interventions Targeting Low-density Malaria Infection (LMI) Among Children in Tanzania
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Incidence of all-cause sick visits
研究概览
简要总结
This trial will assess the long-term health and socioeconomic impact of interventions targeting low-density malaria infection (LMI) among children in Tanzania
详细描述
This is a 3-arm open-label randomized control trial of 600 children aged 6 months to 10 years in Tanzania, where transmission is low and a high proportion of infections are low-density. Standard of care based on passive case detection (PCD) using rapid diagnostic test (control arm) will be compared to two different approaches to detect and treat P. falciparum LMI: active case detection using molecular testing (ACDm) and PCD using molecular testing (PCDm). Aims are:
- To assess the impact of standard PCD plus ACDm vs standard PCD on long-term child health
- To assess the impact of PCDm vs standard PCD on long-term child health
- To evaluate the cost-effectiveness of ACDm and PCDm
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
- None
盲法说明
This will be an open label randomized controlled trial. Participants and personnel administering the intervention will be unblinded. Assessment of the primary outcome will be unblinded. Assessment of several secondary outcomes will be blinded as feasible.
入排标准
- 年龄范围
- 6 Months 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •6 months to 10 years of age of age at enrollment
- •Primary residence in the study area during the study period
- •Agree to come to study clinic for any illness
- •Agree to avoid medications outside the study, even herbal medication
排除标准
- •Another child from household already randomly selected for recruitment
- •Not able or does not provide informed consent
- •Need for emergency intervention
- •Known history of chronic illness requiring regular specialty care including diabetes mellitus, cancer, or Stage 3 or 4 HIV/AIDS
- •Contraindications to artemether-lumefantrine (AL) including history of allergic reaction, weight under 5 kg
- •Participation in another active/ongoing intervention trial
研究组 & 干预措施
Active Case Detection using molecular testing (ACDm)
Per standard of care, children will receive passive case detection (PCD) using rapid diagnostic test (RDT) if they present with fever.
Children will receive malaria active case detection (ACD) using RDT and qPCR (quantitative polymerase chain reaction) three times yearly with treatment using artemether-lumefantrine (AL) if RDT or qPCR positive.
干预措施: Active case detection using molecular testing (ACDm) (Other)
Passive Case Detection using molecular testing (PCDm)
Children who present with fever will receive PCD using RDT and qPCR with treatment using AL if RDT or qPCR positive.
Per standard of care, children will not receive malaria ACD.
干预措施: Passive case detection using molecular testing (PCDm) (Other)
Standard passive case detection (PCD)
Per standard of care, children will receive PCD using RDT.
Per standard of care, children will not receive malaria ACD.
干预措施: Control (standard of care) (Other)
结局指标
主要结局
Incidence of all-cause sick visits
时间窗: 24-30 months from enrollment
Number of sick visits to health facility per person time, excluding planned admissions for medical care, elective surgery, and trauma.
次要结局
- Prevalence of anemia(24-30 months from enrollment)
- Prevalence of vomiting following administration of study drugs(24-30 months from enrollment)
- Prevalence of underweight status(24-30 months from enrollment)
- Prevalence of wasting(24-30 months from enrollment)
- Prevalence of stunting(24-30 months from enrollment)
- Prevalence of malnutrition(24-30 months from enrollment)
- Incidence in antibiotics prescribed(24-30 months from enrollment)
- Cognitive ability among children 6-12 years of age on the East Africa Neurodevelopment Assessment Tool(24-30 months from enrollment)
- School performance(24-30 months from enrollment)
- Socioeconomic costs to health system(24-30 months from enrollment)
- All-cause fever episodes(24-30 months from enrollment)
- Incidence of clinical symptoms(24-30 months from enrollment)
- Incidence of clinical malaria(24-30 months from enrollment)
- Proportion of fever episodes with clinical failure(24-30 months from enrollment)
- Prevalence of parasitemia(24-30 months from enrollment)
- Cognitive ability among children 0-3.4 years of age on the Global Scales of Early Development (GSED)(24-30 months from enrollment)
- Cognitive ability among children 3.5-5 years of age on the International Development and Early Learning Assessment (IDELA)(24-30 months from enrollment)
- Sustained attention among children 5-8 years of age on the Pencil Tapping Test(24-30 months from enrollment)
- Socioeconomic costs to participant(24-30 months from enrollment)
- Sustained attention among children 9-12 years of age on the Code Transmission Test, a local adaptation of the Test of Everyday Attention for Children(TEA-Ch)(24-30 months from enrollment)
- Incidence of wasting(24-30 months from enrollment)
- Proportion with biomarkers of inflammation(24-30 months from enrollment)
- Incidence of school absenteeism(24-30 months from enrollment)
- Cost effectiveness(24-30 months from enrollment)
- Prevalence of systemic inflammation(24-30 months from enrollment)
- Proportion with general antibody responses to vaccines(24-30 months from enrollment)
- Socioeconomic costs to family(24-30 months from enrollment)
- Proportion with antimalarial antibodies against P.falciparum(24-30 months from enrollment)
- Incidence of adverse events (AEs)(24-30 months from enrollment)
- Proportion with general antibody responses to common pathogens(24-30 months from enrollment)
- Incidence of stunting(24-30 months from enrollment)