跳至主要内容
临床试验/NCT02533336
NCT02533336终止3 期

The Effectiveness of Non-Pyrethroid Insecticide-Treated Durable Wall Liners as a Method for Malaria Control in Endemic Rural Tanzania: Cluster Randomized Trial

National Institute for Medical Research, Tanzania1 个研究点 分布在 1 个国家目标入组 4,917 人开始时间: 2015年11月9日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
终止
发起方
入组人数
4,917
试验地点
1
主要终点
Incidence of malaria parasitemia

研究概览

简要总结

Over one year period in an area with universal coverage of LLIN and ACT provision as the first-line treatment of malaria, the investigators intend to evaluate the impact of DL on malaria transmission as measured by the incidence of malaria parasitemia, the prevalence of moderate to severe anemia, and entomological parameters. Information on the relative cost-effectiveness estimates of DL and the community acceptability of DL will also be measured.

详细描述

Vector control, together with prompt treatment with an artemisinin-based combination therapy (ACT) for individuals diagnosed with malaria and intermittent preventive treatment in pregnant women, is a critical component of malaria control in Africa. The two main vector control interventions used in Africa are long-lasting insecticidal nets (LLINs) and indoor residual spraying (IRS). LLINs are currently the mainstay of vector control and are believed to have contributed to the recent dramatic decline in malaria cases. However, resistance to the pyrethroid insecticides used in the bed nets has increased. The second main vector control method, IRS, has been an extremely effective adjunct to LLINs; its usefulness is threatened by the high cost of repeated applications and increasing mosquito resistance to insecticides used for spraying.

A new product, durable lining (DL) treated with non-pyrethroid insecticides, has been developed by Vestergaard, which theoretically mimics the effect of IRS but is designed to last for a minimum of three years. The product consists of a mixture of two non-pyrethroid insecticides incorporated into a polymer fabric that are designed to migrate differentially over the lifetime of the product to ensure sustained bioefficacy. The use of two agents may also decrease the risk of development of resistance. It is estimated that the cost of the insecticide treated wall liners (DL), which are installed on the indoor walls of houses, would be equal to 2-3 rounds of IRS.

To test the effectiveness of this new product, we will conduct a two-arm controlled randomized cluster trial to test the hypothesis that DL + LLINs are superior to LLINs alone. Over twelve (12) months (August 2015- Aug 2016), in an area with universal coverage (UC) of LLINs and where artemisinin combination therapies (ACT) are provided as the first-line treatment of malaria, we intend to evaluate the impact of DL on malaria transmission among children ages 6 months to 11 years as measured by the incidence of malaria parasitemia (symptomatic and asymptomatic), and the prevalence of moderate to severe anemia in under-fives. In addition, we will assess the effect of DL on entomological parameters, and measure the acceptability and a cost-effectiveness of the intervention. Stratified randomization based on malaria prevalence during the baseline survey will be used to select 22 clusters per arm in Muheza district.

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
6 Months 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

DL+LLINs

Experimental

DL treated with abamectin and fenpyroximate

干预措施: abamectin and fenpyroximate (Drug)

结局指标

主要结局

Incidence of malaria parasitemia

时间窗: 1 year

The primary end point of the study is the cumulative incidence of malaria parasitaemia (asymptomatic or symptomatic) defined as the number of mRDT-confirmed episodes of parasitaemia per person-year

次要结局

  • Effectiveness of DL on anemia(1 year)

研究者

发起方
National Institute for Medical Research, Tanzania
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Dr. Geofrey Makenga

Research Scientist

National Institute for Medical Research, Tanzania

研究点 (1)

Loading locations...

相似试验

The Effectiveness of Non-Pyrethroid... | 临床试验