Attractive Targeted Sugar Bait Phase III Trial in Zambia
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 3,480
- 试验地点
- 1
- 主要终点
- Clinical malaria case incidence
研究概览
简要总结
The trial will evaluate the efficacy of ATSB deployment plus universal coverage of a WHO core vector control (VC) interventions over two transmission seasons on a minimum 30% reduction in cohort clinical disease incidence, confirmed case incidence, and parasite prevalence, as compared with VC alone. Measurement of entomological outcomes, assessment of acceptability and barriers to uptake and consistent use of ATSB, safety and adverse event monitoring and estimation of the cost and cost-effectiveness of ATSB will also occur.
详细描述
An open-label two-arm cluster randomized controlled trial (CRCT) design will be used comparing ATSB + LLINS vs LLINS alone (standard of care). A cluster trial design is indicated given the intended community-level effect of ATSBs on malaria transmission. Universal LLIN coverage will be ensured in both arms prior to start of the study and will serve as the standard of care. Arm 1 will receive ATSBs for two years. Arm 2 will receive the standard of care of universal LLIN coverage.
Sixty clusters will be used for the trial per site, with 30 clusters allocated to the ATSB intervention plus universal LLIN coverage arm, and 30 clusters allocated to the control with standard of care arm, universal LLIN coverage. Restricted randomization will be used to randomize the 60 clusters to intervention and control arms. The incidence cohort and cross-sectional household surveys will each be powered to detect a 30% reduction in the malaria outcome over two years.
Primary aim:
• Quantify the efficacy of ATSBs for reducing P. falciparum clinical case incidence, parasite prevalence, community infection incidence, and health facility confirmed malaria case incidence.
Secondary aims include:
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
- 12 Months 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Household resident
- •≥12 months and <15 years of age at the time of enrollment
- •If age 12 months - 6 years of age, parent or guardian provides consent for child's participant
- •If age 7-14 years, parent or guardian provides consent for child's participant and child provides assent for participation
排除标准
- •Residence within the buffer zone
- •Age <12 months or ≥15 years of age at the time of cohort enrollment
- •Household contained a participant in the first cohort (for participation in the second cohort)
- •Pregnant at the time of cohort enrollment. Pregnant adolescents are excluded because they are eligible for protection from infection through pregnancy standard of care - intermittent preventative therapy during pregnancy (IPTp), and to avoid undue discomfort with repeated blood sampling.
- •Pregnancy at any time during the cohort study. Pregnancy will be identified in adolescents at enrollment and follow-up visits through a single question regarding pregnancy status during each cohort visit. When an adolescent indicates that she is pregnant or is unsure of her pregnancy status, she will no longer be followed for ongoing blood testing for the reasons noted above and will be censored in the analysis.
- •Does not provide consent/assent required according to age to participate in the study
结局指标
主要结局
Clinical malaria case incidence
时间窗: Seasonal (6 months)
Clinical malaria case incidence measured by cohort and defined as fever (history of fever in the past 48 hours or an axillary temperature ≥37.5o C. at follow-up visit) plus a positive RDT in children ≥12 months and \<15 years in age.
次要结局
- Prevalence, detected by RDT(6 weeks)
- Prevalence, detected by PCR(6 weeks)
- Time to first infection(Seasonal (6 months))
- Incidence rate of passively reported clinical malaria(Seasonal (6 months))
研究者
John M. Miller, PhD
Senior Malaria Technical Advisor
PATH