NCT02671175已完成3 期
Malaria Chemoprevention With Monthly Treatment With Dihydroartemisinin-piperaquine for the Post-discharge Management of Severe Anaemia in Children Aged Less Than 5 Years in Uganda and Kenya: A Two-arm Randomised Placebo Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,049
- 试验地点
- 9
- 主要终点
- All-cause deaths or all-cause re-admissions by 26 weeks from randomization (composite primary outcome).
研究概览
简要总结
This study evaluates the efficacy and safety of 3 months of malaria chemoprevention post-discharge using dihydroartemisinin piperaquine (DHA-P) in children under 5 years of age admitted with severe anemia. One half will receive monthly DHA-P and the other half placebo.
详细描述
Children hospitalized with severe anemia 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 with monthly 3-day treatment courses of artemether-lumefantrine (AL) in children with severe malarial anemia prevented 31% of deaths and readmissions. This study is a confirmatory efficacy trial in Kenya and Uganda to determine the efficacy and safety of malaria chemoprevention post-discharge. We hypothesize that an additional three months of malaria chemoprevention with monthly 3-day treatment courses with DHA-piperaquine (each providing about 4 weeks of post-treatment prophylaxis) provided during the post-discharge period to children recently admitted with severe anemia is superior to reduce all-cause readmission and mortality rates by 6 months compared with 2 weeks of post-treatment prophylaxis provided by the single course of oral AL when given as part of the standard in-hospital care around the time of discharge.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- — 至 60 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pre-study screening
- •Haemoglobin <5.0 g/dl or PCV < 15%, or requirement for blood transfusion for other clinical reasons on or during admission to the hospital
- •Aged less than 59.5 months
- •Body weight >5 kg
- •Resident in catchment area Enrolment in study(t=0)
- •Fulfilled the pre-study screening eligibility criteria
- •Aged < 59.5 months
- •Clinically stable, able to take oral medication
- •Subject completed blood transfusion(s) or became clinically stable without transfusion
- •Able to feed (for breastfeeding children) or eat (for older children)
- •Absence of know cardiac problems
- •Provision of informed consent by parent or guardian Randomisation (t=2 weeks)
- •Fulfilled enrolment eligibility criteria and was enrolled during recent admission
- •Aged <60 months
- •Still clinically stable, able to take to oral medication, able to feed (for breastfeeding children) or eat (for older children) and able to sit unaided (for older children who were already able to do so prior to hospitalisation)
排除标准
- •Pre-study screening
- •Recognised specific other cause of severe anaemia (e.g. trauma, haematological malignancy, known bleeding disorder)
- •Known sickle cell disease
- •Anticipated to reach the 5th birthday (60 months of age) within 2 weeks from enrolment (i.e. prior to randomization)
- •Child will reside for more than 25%of the 6 months study period (i.e. 6 weeks or more) outside of catchment area Enrolment in study (t=0)
- •Previous enrolment in the present study
- •Known hypersensitivity to study drug
- •Sickle cell disease
- •Use or known need at the time of enrolment for concomitant prohibited medication during the 14 weeks PMC treatment period.
- •Ongoing or planned participation in another clinical trial involving ongoing or scheduled treatment with prohibited medicinal products or active follow-up during the course of the study (6 months from enrolment)
- •A known need at the time of enrolment for scheduled surgery during the subsequent course of the study (6 months from enrolment)
- •Suspected non-compliance with the follow-up schedule
- •Know heart conditions, or family history of congenital prolongation of the QTc interval.
- •Taking medicinal products that are known to prolong the QTc interval Randomisation (t=2 weeks)
- •Used dihydroartemisinin since enrolment
- •Use or known need at the time of randomisation for concomitant prohibited medication during the 14 weeks PMC treatment period.
- •Enrolled, or known agreement to enrol into another clinical trial involving ongoing or scheduled treatment with medicinal products during the course of the study (6 months from enrolment)
- •A known need at the time of randomisation for scheduled surgery during the subsequent course of the study (6 months from enrolment)
- •Suspected non-compliance with the follow-up schedule
- •Withdrawal of consent since enrolment
研究组 & 干预措施
dihydroartemisinin-piperaquine
Active Comparator
dihydroartemisinin-piperaquine (3-day treatment courses, given 2, 6, and 10 weeks after enrollment)
干预措施: dihydroartemisinin-piperaquine (Drug)
dihydroartemisinin-piperaquine Placebo
Placebo Comparator
Placebo comparator (matching tablets containing no active ingredients)
干预措施: dihydroartemisinin-piperaquine placebo (Drug)
结局指标
主要结局
All-cause deaths or all-cause re-admissions by 26 weeks from randomization (composite primary outcome).
时间窗: 6 months
Primary outcome
次要结局
- Malaria infection at 6 month(6 month)
- Readmission due to severe malaria-specific anaemia (severe anaemia plus parenteral or oral antimalarial treatment and parasite density >5000/microlitre) by 26 weeks from randomization(26 weeks from randomization)
- Adverse events by 26 weeks from randomization(26 weeks from randomization)
- Patients costs related to treatment of the primary disease, readmission or death(26 weeks after randomization)
- The costs of the health system of treating the primary disease and anaemia, as well as treatment of readmissions or costs related to fatalities(26 weeks after randomization)
- Non-severe all-cause sick-child clinic visits by 26 weeks from randomization(26 weeks from randomization)
- Non-malaria sick child clinic visits by 26 weeks from randomization(26 weeks from randomization)
- Serious adverse events within 7 days after the start of each course of PMC, excluding primary and secondary efficacy outcomes.(26 weeks from randomization)
- Readmission due to severe malaria (defined as any treatment with parenteral quinine or artesunate, or presence of severe anaemia and treatment with oral antimalarials) by 26 weeks from randomization(26 weeks from randomization)
- Readmissions due to severe anaemia (defined as Haemoglobin (Hb) <5g/dL or packed-cell volume (PCV) <15% or requirement for blood transfusion based on other clinical indication)by 26 weeks from randomization(26 weeks from randomization)
- Readmission due to severe malarial anaemia (severe anaemia plus parenteral or oral antimalarial treatment)by 26 weeks from randomization(26 from randomization)
- All-cause mortality by 26 weeks from randomization(26 weeks from randomization)
- Any anaemia (Hb<11 g/dL), mild anaemia (Hb 8.0-10.99 g/dl) moderate anaemia (Hb 5.0-7.99 g/dL) and severe anaemia (Hb<5 g/dL) at 6 months(6 months)
- Readmission due to severe anaemia or severe malaria (composite outcome)by 26 weeks from randomization(26 weeks from randomization)
- Readmission due to severe disease other than severe anaemia and severe malaria by 26 weeks from randomization(26 weeks from randomization)
- Weight-for-age, height-for-age, and height-for-weight Z-scores, standard deviation (SD) scores of reference population) at 6 months(6 months)
- All-cause readmission by 26 weeks from randomization(26 weeks from randomization)
- Clinic visits because of smear of rapid diagnostic test (RDT) confirmed non-severe malaria by 26 weeks from randomization(26 weeks from randomization)
- Hb at 6 months(6 months)
- Serious adverse events, excluding primary and secondary efficacy outcomes, by 26 weeks from randomization(26 weeks from randomization)
- Adverse events within 7 days after start of each course of PMC.(7 days post drug administration)
- Corrected QT interval (QTc) prolongation measured by electro cardio gram (ECG)4-6 hours after 3rd dose of each course(4-6 hours after 3rd dose of each course)
- Patients costs of receiving the intervention(26 weeks after randomization)
- The costs of the health care system of providing the intervention(26 weeks after randomization)
研究者
研究点 (9)
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