Repeat Ivermectin Mass Drug Administrations for Control of Malaria: a Pilot Safety and Efficacy Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 2,712
- 试验地点
- 2
- 主要终点
- Incidence of Clinical Malaria Episodes
研究概览
简要总结
The purpose of this study is to determine whether repeated ivermectin mass drug administrations to Burkinabé villagers, performed in three week intervals over the rainy-season, is well-tolerated and safe, and also effective in reducing local malaria transmission and thus clinical malaria episodes in treated village children.
详细描述
Primary Objective: To determine the efficacy of repeated ivermectin mass drug administrations (IVM MDA) (150 µg/kg), given to the population of eligible patients in enrolled villages, for reducing the cumulative incidence of uncomplicated malaria episodes in enrolled village children (≤ 5 years of age) over the course of the treatment.
Hypothesis: Repeated IVM MDA starting at the beginning of the rainy season will be well tolerated and safe, and will reduce clinical malaria episodes in children by significantly reducing malaria transmission among treated villages.
Overview Study Design: Single-blind (outcomes assessor); parallel assignment with 2 arms; cluster-randomized control trial to determine the effect of repeated IVM MDA on malaria transmission and clinical malaria episodes. The unit of randomization will be the village (cluster). 8 villages total will be enrolled in two arms. The active comparator arm (4 villages) will receive a single standard MDA (IVM; 150-200 µg/kg + albendazole; 400 mg) soon after the start of the rainy season, while the experimental arm (4 villages) will receive the standard MDA on the same date, plus 5 more IVM MDA at 3 week intervals thereafter. The primary endpoint will be the cumulative incidence of clinical malaria episodes in children ≤5 year of age within each village.
Sites: This study will be conducted in villages along the main east-west and north-south road corridors in the Sud-Ouest administrative region of Burkina Faso.
Study Population: Indigenous Burkinabé from various ethnic groups (Dagara, Bobo, Lobi, Mossi, etc.). The entire eligible population of each enrolled village will receive the MDAs, following the standard inclusion/exclusion criteria of MDA for control of microfilaremia caused by Wuchereria bancrofti (lymphatic filariasis; LF). Clinical incidence of malaria will be assessed only in children living in enrolled villages who are ≤ 5 years of age, most of whom will not have received any treatment due to the standard MDA exclusion criteria of children < 90 cm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Residence in the study site
- •Able to understand the information and willing to give consent and assent (parent or guardian consent if study participant age is < 18 years)
排除标准
- •Residence outside of in the study site
- •Height ≤ 90 cm
- •Permanent disability, serious medical illness that prevents or impedes study participation and/or comprehension
- •Pregnancy
- •Breast feeding if infant is within 1 week of birth
- •Known allergy to the study drugs
研究组 & 干预措施
Single MDA
Single mass drug administration of ivermectin (150 µg/kg) + albendazole (400 mg) performed after the start of the rainy season as part of public health efforts to eliminate lymphatic filariasis.
干预措施: Ivermectin (Drug)
Single MDA
Single mass drug administration of ivermectin (150 µg/kg) + albendazole (400 mg) performed after the start of the rainy season as part of public health efforts to eliminate lymphatic filariasis.
干预措施: Albendazole (Drug)
Repeated MDA
Same at Active Comparator, but then followed by five more mass drug administrations of ivermectin only (150 µg/kg) every three weeks thereafter.
干预措施: Ivermectin (Drug)
Repeated MDA
Same at Active Comparator, but then followed by five more mass drug administrations of ivermectin only (150 µg/kg) every three weeks thereafter.
干预措施: Albendazole (Drug)
结局指标
主要结局
Incidence of Clinical Malaria Episodes
时间窗: Approximately 18 weeks, from the start of the first MDA to 3 weeks following the last MDA in the Experimental arm
Cumulative incidence of malaria episodes in a cohort of village children ≤ 5 years of age (as assessed by active case surveillance in study villages - malaria episode defined as ≥38.0°C fever or history of fever in the last 24 hours + positive rapid diagnostic test for Plasmodium falciparum). Incidence is reported as malaria episodes per child over the course of the trial, a higher incidence is a worse outcome.
次要结局
- Adverse Events(Approximately 18 weeks, from the start of the first MDA to 3 weeks following the last MDA in the Experimental arm)
- Entomological Indicator of Parasite Transmission(Approximately 20 weeks, from before the start of the first MDA to 4 weeks following the last MDA in the Experimental arm)
- Molecular Force of P. Falciparum Infection(Approximately 18 weeks, from the start of the first MDA to 3 weeks following the last MDA in the Experimental arm)
- Number of 6-10 Year Old Participants With Soil Transmitted Helminths (STH)(Approximately 20 weeks, from before the start of the first MDA to 4 weeks following the last MDA in the Experimental arm)
- Entomological Inoculation Rate(6 sampling periods over 18 weeks, starting in week 2 following the first MDA, and sampling every 3 weeks thereafter until week 17 of the treatment phase.)