Malaria Chemoprevention With Monthly Treatment With Dihydroartemisinin-Piperaquine for the Post-discharge Management of Severe Anaemia in Children Less Than 5 Years in Malawi
试验速览
- 阶段
- 3 期
- 入组人数
- 375
- 试验地点
- 1
- 主要终点
- Proportion of those with 100 % uptake of PMC drugs during the 15 weeks of the study period.
研究概览
简要总结
Background and rationale: Children hospitalised with severe anaemia in Africa are at high risk of readmission or death within 6 months after discharge. No strategy specifically addresses this post-discharge period. In Malawi, 3 months of post-discharge malaria chemoprevention (PMC) with monthly 3-day treatment courses of artemether-lumefantrine (AL) in children with severe malarial anaemia prevented 31% of deaths and readmissions. The effect was in addition to the effect of insecticide-treated bednets. There is now need to design and evaluate effective delivery mechanism for PMC within the health system.
详细描述
Objectives: The primary objective of the trial is to determine the optimum PMC delivery mechanism by comparing community- versus health facility-based strategies in order to inform policy.
Study Type: This is a single-centre, matched, cluster randomized, 5-arm, factorial design trial comparing the uptake of PMC-DHP delivered through health facility or community-based approaches with or without SMS/HSA reminders.
Site: 90 villages in the catchment areas of Zomba Central hospital in southern Malawi
Study Population:
Inclusion criteria: convalescent children aged less than 5 years and weighing >5 kg admitted with severe anaemia (haemoglobin<5g/dL / Ht<15%); clinically stable, able to take or switch to oral medication; post-transfusion Hb >5g/dL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 4 Months 至 59 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Haemoglobin <5.0g/dl or PCV <15%, or requirement for blood transfusion for other clinical reasons on or during admission to the hospital
- •Age between 4 months (inclusive) and 59 months (inclusive)
- •Body weight >5kgs
- •Screening (in-hospital):
- •Fulfilled the pre-study screening eligibility criteria
- •Clinically stable, able to switch to oral medication
- •Subject completed blood transfusion(s) in accordance with routine hospital practice
- •Able to feed (for breastfed children) or eat (for older children)
- •Absence of known cardiac problems
- •Provision of informed consent by parent or guardian
- •Randomization (at discharge):
- •Fulfilled screening eligibility criteria
- •Still clinically stable, able to take oral medication, able to feed (for breastfed children) or eat (for older children) and able to sit unaided (for older children who were able to do so prior to hospitalization
排除标准
- •Recognised specific other cause of severe anaemia (e.g. trauma, haematological malignancy, known bleeding disorder)
- •Known sickle cell
- •Child will reside for more than 25% of the 3.5months study period (i.e. 3 weeks or more) outside of catchment area Enrolment in the study (t=0) at discharge
- •Previous enrolment in the present study
- •Known hypersensitivity to study drug
- •Sickle cell disease
- •Known need at the time of enrolment for concomitant prohibited medication during the 14 weeks PMC treatment period.
- •On-going or planned participation into another clinical trial involving on-going or scheduled treatment with medicinal products during the course of the study (3.5 months from enrolment)
- •Known need, or scheduled surgery during the course of the study (3.5 months)
- •Suspected non-compliance with the follow-up schedule
- •Known heart conditions, or family history of congenital prolongation of the QTc interval
研究组 & 干预措施
Drug + short message(SMS) reminder
dihydroartemesinin-piperaquine (3-day treatment courses, given 2, 6, and 10 weeks after enrolment) with SMS reminders prior to each treatment course
干预措施: dihydroartemisinin-piperaquine (Drug)
Drug + short message(SMS) reminder
dihydroartemesinin-piperaquine (3-day treatment courses, given 2, 6, and 10 weeks after enrolment) with SMS reminders prior to each treatment course
干预措施: short message(SMS) reminder (Other)
Drug + no short message(SMS) reminder
dihydroartemisinin-piperaquine (3-day treatment courses, given 2, 6, and 10 weeks after enrolment) without SMS reminders prior to each treatment course.
干预措施: dihydroartemisinin-piperaquine (Drug)
Drug+ Health worker reminder
dihydroartemisinin-piperaquine (3-day treatment courses, given 2, 6, and 10 weeks after enrolment) with Health surveillance assistants reminders prior to each treatment course.
干预措施: dihydroartemisinin-piperaquine (Drug)
Drug+ Health worker reminder
dihydroartemisinin-piperaquine (3-day treatment courses, given 2, 6, and 10 weeks after enrolment) with Health surveillance assistants reminders prior to each treatment course.
干预措施: Health worker reminder (Other)
Drug at hospital + SMS reminder
dihydroartemisinin-piperaquine (3-day treatment courses, given 2, 6, and 10 weeks after enrolment) collected at the outpatient department without an SMS reminders prior to each treatment course.
干预措施: dihydroartemisinin-piperaquine (Drug)
Drug at Hospital+no SMS reminder
dihydroartemisinin-piperaquine (3-day treatment courses, given 2, 6, and 10 weeks after enrolment) collected at the outpatient department with a short message reminder prior to each treatment course
干预措施: dihydroartemisinin-piperaquine (Drug)
Drug at Hospital+no SMS reminder
dihydroartemisinin-piperaquine (3-day treatment courses, given 2, 6, and 10 weeks after enrolment) collected at the outpatient department with a short message reminder prior to each treatment course
干预措施: message(SMS) reminder (Other)
结局指标
主要结局
Proportion of those with 100 % uptake of PMC drugs during the 15 weeks of the study period.
时间窗: 15 weeks
100 % uptake is defined as administration of all study drugs and compliance to study visits during the course of 15 weeks.
次要结局
- Proportion of those with 60% uptake of PMC drugs during the 15 weeks of the study period.(15 weeks)
- Proportion of those with 30 % uptake of PMC drugs during the 15 week trial period.(15 weeks)
- Proportion of those with <30% uptake of PMC drugs during the 15 week trial period.(15 weeks)