Enhancing Immunity to Malaria in Young Children With Effective Chemoprevention
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 924
- 试验地点
- 1
- 主要终点
- Incidence of symptomatic malaria following cessation of IPTc
研究概览
简要总结
The MIC-DroP trial will test the hypothesis that preventing early life blood-stage malaria antigenic exposure with intermittent preventive therapy (IPT) enhances protective immunity to malaria. This study will take advantage of a unique opportunity to study infants born to mothers followed in a NIH-funded randomized controlled trial of novel intermittent preventive therapy in pregnancy (IPTp) regimens (NCT04336189). MIC-DroP will leverage the parent IPTp study to enroll 924 children who will be randomized at 8 weeks of age to receive no intermittent preventive therapy in childhood (IPTc), monthly DP from 8 weeks to 1 year of age, or monthly DP from 8 weeks to 2 years of age, and then follow children to 4 years of age. The primary outcome of this study will be to compare the incidence of malaria from 2 to 4 years of age among children randomized to receive no IPTc, monthly DP for the first year of life, or monthly DP for the first two years of life. Investigators will also leverage this trial to evaluate immune development during early childhood.
详细描述
This study is a phase III, double-blind, randomized controlled trial of 924 HIV- uninfected children. Children born to mothers enrolled in an ongoing clinical trial of different IPTp arms in pregnancy (NCT 04336189) will be enrolled in this study. In the parent IPTp study, 2757 HIV-uninfected pregnant women will be randomized to receive IPTp with monthly sulfadoxine pyrimethamine (SP) alone, monthly DP alone, or both monthly SP+DP, and followed through 4 weeks postpartum. At the 4-week postpartum visit, we will enroll and randomize 924 eligible children to one of three IPTc arms: no IPTc (the current standard of care), monthly DP from 8 weeks to 1 year of age, or monthly DP from 8 weeks to 2 years of age. Study drugs will be placebo controlled and all doses of study drug will be given by directly observed therapy (DOT). The intervention phase will be completed at 2 years of age, and children followed through 4 years of age. Study participants will be followed for all of their outpatient medical care in our dedicated study clinic. Malaria incidence will be measured via active case detection. Routine assessments will be performed in the study clinic for all study participants every 4 weeks, including passive surveillance for parasitemia by quantitive polymerase chain reaction (qPCR). Venous blood will be collected for immunologic assays three times annually from 8 weeks to 4 years of age. All maternal assessments conducted during the parent IPTp study, including assessment for maternal malaria exposure (e.g., placental histology) household survey, will be available and linked to each study participant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Administration of all study drugs will be double blinded. All doses of study drugs will be prepackaged by a study pharmacist and administered by a study nurse blinded to the study participant's treatment regimen. All 3 daily doses will be directly observed in the clinic. If a study participant vomits the study drug within 30 minutes of administration, the drug will be re-administered. All doses of study drugs will be given between 8 and 104 weeks (2 years) of age.
入排标准
- 年龄范围
- — 至 2 Months（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Born to HIV-uninfected mother enrolled in parent clinical trial of intermittent preventative treatment of malaria in pregnancy (IPTp-SP vs. IPTp-DP vs. IPTp-SP+DP, NCT 04336189)
- •Resident of Busia District
- •Provision of informed consent by parent/guardian
- •Agreement to present for any illness and avoid, where possible, medications outside the study protocol.
排除标准
- •Intention of moving outside Busia district during the study period
- •Active medical problem requiring in-patient evaluation or chronic medical condition requiring frequent medical attention
研究组 & 干预措施
IPTc DP 1 year
DP given from 8 weeks to 52 weeks of age; DP placebo given from 52 weeks to 104 weeks of age; No IPTc in third and fourth years of follow-up.
干预措施: Dihydroartemisinin-piperaquine (DP) (Drug)
IPTc DP 1 year
DP given from 8 weeks to 52 weeks of age; DP placebo given from 52 weeks to 104 weeks of age; No IPTc in third and fourth years of follow-up.
干预措施: DP Placebo (Other)
IPTc DP 2 years
DP given from 8 weeks to 104 weeks of age; No IPTc in third and fourth years of follow-up.
干预措施: Dihydroartemisinin-piperaquine (DP) (Drug)
No IPTc
DP placebo given from 8 weeks to 104 weeks of age; No IPTc in third and fourth years of follow-up.
干预措施: DP Placebo (Other)
结局指标
主要结局
Incidence of symptomatic malaria following cessation of IPTc
时间窗: 2 years to 4 years of age
The incidence of symptomatic malaria, defined as the number of incident episodes of malaria requiring treatment per time at risk, during the period after the intervention was given (2-4 years of age). Treatments within 14 days of a prior episode are not considered incident events.
次要结局
- Incidence of complicated malaria(2 years to 4 years of age)
- Prevalence of anemia(2 years to 4 years of age)
- Prevalence of parasitemia(2 years to 4 years of age)
- Incidence of hospital admissions and/or deaths(2 years to 4 years of age)
研究者
Grant Dorsey, M.D, Ph.D.
Professor
University of California, San Francisco