Malaria Elimination Initiative, Institute of Global Health Sciences, University of California, San Francisco, San Francisco, California, USA
Ifakara Health Institute, Bagamoyo, Tanzania, United Republic of.
BMJ Open. 2024 Mar 27;14(3):e082227. doi: 10.1136/bmjopen-2023-082227.
As malaria declines, low-density malaria infections (LMIs) represent an increasing proportion of infections and may have negative impacts on child health and cognition, necessitating development of targeted and effective solutions. This trial assesses the health, cognitive and socioeconomic impact of two strategies for detecting and treating LMI in a low transmission setting.
The study is a 3-arm open-label individually randomised controlled trial enrolling 600 children aged 6 months to 10 years in Bagamoyo district, Tanzania. Children are randomised to one of three arms: active case detection with molecular (ACDm) testing by high volume quantitative PCR (qPCR), passive case detection also with molecular testing (PCDm) and a control of standard PCD using rapid diagnostics tests (RDTs). Over the 2-year trial, ACDm participants receive malaria testing using RDT and qPCR three times annually, and malaria testing by RDT only when presenting with fever. PCDm and PCD participants receive malaria testing by RDT and qPCR or RDT only, respectively, when presenting with fever. RDT or qPCR positive participants with uncomplicated malaria are treated with artemether lumefantrine. The primary outcome is cumulative incidence of all-cause sick visits. Secondary outcomes include fever episodes, clinical failure after fever episodes, adverse events, malaria, non-malarial infection, antibiotic use, anaemia, growth faltering, cognition and attention, school outcomes, immune responses, and socioeconomic effects. Outcomes are assessed through monthly clinical assessments and testing, and baseline and endline neurodevelopmental testing. The trial is expected to provide key evidence and inform policy on health, cognitive and socioeconomic impact of interventions targeting LMI in children.
Study is approved by Tanzania NatHREC and institutional review boards at University of California San Francisco and Ifakara Health Institute. Findings will be reported on ClinicalTrials.gov, in peer-reviewed journals and through stakeholder meetings.
NCT05567016.
随着疟疾的减少，低密度疟疾感染（LMIs）在感染中的比例不断增加，可能对儿童的健康和认知产生负面影响，因此需要开发有针对性和有效的解决方案。本试验评估了在低传播环境中，通过两种策略检测和治疗低密度疟疾感染对儿童健康、认知和社会经济的影响。
本研究是一项 3 臂开放性标签个体随机对照试验，在坦桑尼亚巴加莫约区招募了 600 名 6 个月至 10 岁的儿童。儿童被随机分为三组：主动病例检测与分子检测（ACDm），使用高容量定量 PCR（qPCR）进行检测；被动病例检测与分子检测（PCDm）；标准 PCD 用快速诊断检测（RDTs）。在为期 2 年的试验中，ACDm 参与者每年接受 3 次 RDT 和 qPCR 疟疾检测，当出现发热时仅接受 RDT 疟疾检测。PCDm 和 PCD 参与者在出现发热时分别接受 RDT 和 qPCR 或 RDT 疟疾检测。RDT 或 qPCR 阳性的无症状疟疾患者接受青蒿琥酯-甲氟喹治疗。主要结局是全因就诊的累积发病率。次要结局包括发热发作、发热发作后的临床失败、不良事件、疟疾、非疟疾感染、抗生素使用、贫血、生长迟缓、认知和注意力、学校成绩、免疫反应和社会经济影响。通过每月的临床评估和检测，以及基线和终点神经发育测试来评估结局。该试验有望提供关键证据，并为针对儿童低密度疟疾感染的干预措施的健康、认知和社会经济影响提供政策建议。
本研究得到了坦桑尼亚 NatHREC 和加利福尼亚大学旧金山分校和 Ifakara 卫生研究所的机构审查委员会的批准。研究结果将在 ClinicalTrials.gov 上报告，并在同行评议期刊和利益相关者会议上发表。
NCT05567016。
