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临床试验/NCT04864444
NCT04864444已完成不适用

Mass Drug Administration With Dihydroartemisinin-piperaquine and Primaquine to Reduce Malaria in a Moderate-low Transmission Setting in Senegal: A Cluster Randomized Controlled Trial

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 10,715 人开始时间: 2021年6月19日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
10,715
试验地点
1
主要终点
Difference in village-level confirmed incidence of malaria

研究概览

简要总结

This community-based cluster randomized controlled trial aims to evaluate the effectiveness of time-limited, community-wide mass drug administration (MDA) with dihydroartemisinin-piperaquine (DHA-PPQ) and single low-dose primaquine (SLD-PQ) on Plasmodium falciparum transmission compared to standard-of-care seasonal malaria chemoprevention (SMC). The study will be conducted in a moderate-to-low malaria transmission setting of Senegal with optimized malaria control measures (e.g., proactive community case management and piperonyl butoxide pyrethroid long-lasting insecticidal nets (PBO LLINS)).

详细描述

Over the past two decades in Senegal, the scale-up of malaria control measures [e.g., access to prompt testing and case management, LLINs, and SMC] has led to a 78% reduction in malaria incidence. However, gains have not been uniform, with lower transmission areas in the north implementing pre-elimination activities and higher transmission areas in the south implementing control interventions (including SMC). The purpose of this study is determine whether MDA will be able to rapidly reduce malaria incidence in areas of moderate-to-low malaria transmission of southern Senegal (where control activities are ongoing) so that the program can reorient their malaria strategy to implement elimination interventions in these settings.

The study aims to deliver three rounds of community-wide MDA with DHA-PPQ + SLD-PQ. MDA drugs will be administered over the course of three days. All three doses of DHA-PPQ will be given via supervised DOT (as per administration of SMC by national malaria guidelines) through a door-to-door approach.

The research objectives are:

  1. To evaluate the impact of three rounds of MDA with DHA-PPQ and SLD-PQ on village-level confirmed malaria case incidence, malaria prevalence, and on reaching a target malaria incidence of <5 cases per 1000 person-years compared to standard-of-care SMC when provided in the context of optimized control (proactive community case management + PBO LLINs).
  2. To determine the cost, coverage, operational feasibility, and acceptability of three rounds of MDA with DHA-PPQ and SLD-PQ compared to standard-of-care SMC.
  3. To determine the impact of three rounds of MDA with DHA-PPQ and SLD-PQ compared to standard-of-care SMC on parasite population dynamics and drug resistance.

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

入排标准

年龄范围
3 Months 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥3 months
  • Willingness to comply with trial procedures and written informed consent to be obtained at the beginning of the study

排除标准

  • Severe illness or self-reported chronic illness (e.g., HIV, tuberculosis, heart/liver/kidney disease, and severe malnutrition)
  • Known hypersensitivity to study drug
  • Additional exclusion criteria for DHA-PPQ:
  • First trimester pregnancy assessed by history and/or urine pregnancy testing
  • Concurrent artemisinin-based combination therapy (ACT) use
  • Taking drugs that influence cardiac function or prolong QTc interval
  • Additional exclusion criteria for PQ:
  • Pregnancy (any trimester) or currently breastfeeding an infant <6 months of age assessed by history and/or urine pregnancy testing
  • <2 years of age

研究组 & 干预措施

MDA with DHA-PPQ + SLD-PQ

Experimental

Participants in intervention villages will be given three rounds of MDA with DHA-PPQ and SLD-PQ. Prior to the intervention, participants will have received piperonyl butoxide (PBO) treated LLINs and proactive community case management. Unlike control villages, MDA-randomized villages will not receive SMC.

干预措施: Dihydroartemisinin-piperaquine (Drug)

MDA with DHA-PPQ + SLD-PQ

Experimental

Participants in intervention villages will be given three rounds of MDA with DHA-PPQ and SLD-PQ. Prior to the intervention, participants will have received piperonyl butoxide (PBO) treated LLINs and proactive community case management. Unlike control villages, MDA-randomized villages will not receive SMC.

干预措施: Primaquine (Drug)

结局指标

主要结局

Difference in village-level confirmed incidence of malaria

时间窗: one year post-MDA

Village-level malaria incidence will be defined as the number of individuals diagnosed with malaria through proactive case detection and passive malaria surveillance at the health facility-level over the total village population measured during census.

次要结局

  • Difference in parasite prevalence by microscopy during high malaria transmission season(3 months after last round of MDA)
  • Difference in parasite prevalence by polymerase chain reaction (PCR) during high malaria transmission season(3 months after last round of MDA)
  • Difference in serological markers of recent infection(3 months after last round of MDA)
  • Difference in the change in prevalence of drug resistance markers(Change from baseline to endline; 1 year period)
  • Difference in the change in prevalence of parasite population dynamics(Change from baseline to endline; 1 year period)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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