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临床试验/NCT01651416
NCT01651416已完成4 期

An Individually Randomised Trial of Seasonal Malaria Chemoprevention Versus a Long-acting Artemisinin Combination Therapy for the Prevention of Malaria and Anaemia in Children Living in an Area of Extended Seasonal Transmission in Ghana.

Centre for Global Health Research, Ghana1 个研究点 分布在 1 个国家目标入组 2,400 人开始时间: 2012年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
2,400
试验地点
1
主要终点
Incidence of malaria cases

研究概览

简要总结

In areas of Africa where malaria is only a problem during a short rainy season, monthly courses of antimalarial drugs can provide very effective prevention of malaria in children. This approach, called intermittent preventive treatment in children (IPTc) but now known as Seasonal Malaria Chemoprevention (SMC), may also be useful in large areas of Africa where malaria is transmitted for longer each year. It is uncertain if IPTc would be effective, acceptable to communities or sustainable when delivered over a longer period, but this is an important public health question of key interest to policy makers, because in areas with a longer transmission season, the burden of malaria is typically higher than in highly seasonal areas.

Another form of prevention that would be operationally easier for African countries to put into practice would be to treat malaria patients with long-lasting antimalarials, which protect children against further malaria episodes for several weeks. Because malaria disproportionately affects certain high risk children more than others, causing repeated attacks of fever and leading to severe anaemia, long-acting drugs may be a simple and effective way to target limited resources at the individuals who most need protection. This may be particularly beneficial where malaria is a seasonal problem, because repeated malaria attacks will not only be borne by a few unfortunate children, but will also occur close together in time.

The investigators propose a clinical trial to evaluate these two forms of chemoprevention in Kumasi, Ghana, an area with an extended malaria transmission season. Children under 5 years of age currently have access to diagnosis and treatment of malaria via by community based health workers. Children enrolled in the study will receive either the standard community-based diagnosis and treatment, treatment with a longer-acting artemisinin combination therapy (ACT), or standard care plus five monthly courses of seasonal malaria chemoprevention (SMC) during the peak in transmission.

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
3 Months 至 59 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged between 3-59 months
  • Care giver or parent willing to participate and have given informed consent
  • Children living in the study area

排除标准

  • Children who are unable to take and retain medication
  • Children who have a severe or chronic illness
  • Children who have a history of serious adverse reaction to the study drugs

研究组 & 干预措施

HMM using short-acting ACT

Active Comparator

Home management of malaria using Artemether-lumefantrine combination (a short-acting ACT) for treatment in children with malaria diagnosed using RDTs

干预措施: Artemether-lumefantrine combination (Drug)

HMM using short-acting ACT plus SMC

Experimental

Home management of malaria using using Artemether-lumefantrine combination (a short-acting ACT) for treatment in children with malaria diagnosed using RDTs plus seasonal malaria chemoprevention with Amodiaquine plus sulphadoxine-pyrimethamine combination.

干预措施: Artemether-lumefantrine combination (Drug)

HMM using short-acting ACT plus SMC

Experimental

Home management of malaria using using Artemether-lumefantrine combination (a short-acting ACT) for treatment in children with malaria diagnosed using RDTs plus seasonal malaria chemoprevention with Amodiaquine plus sulphadoxine-pyrimethamine combination.

干预措施: Amodiaquine plus sulphadoxine-pyrimethamine combination (Drug)

HMM using a long-acting ACT

Experimental

Home management of malaria using Dihydroartemisinin Piperaquine combination (a long-acting ACT) for treatment in children with malaria diagnosed using RDTs

干预措施: Dihydroartemisinin Piperaquine combination (Drug)

结局指标

主要结局

Incidence of malaria cases

时间窗: 12 months

Incidence of malaria cases recorded by the community health workers (CHWs) and at the study health centres. Malaria will be defined as fever or history of fever combined with parasitologically confirmed P. falciparum infection by blood slide. Management of suspected malaria cases reporting to CHWs and health centres will be according to rapid diagnostic test (RDT).

次要结局

  • Proportion of children with parasitaemia(12 months)
  • Incidence of adverse events(12 months)
  • Proportion of children with anaemia(12 months)
  • Number of referrals(12 months)
  • Incidence of severe illness(12 months)

研究者

发起方
Centre for Global Health Research, Ghana
申办方类型
Other
责任方
Principal Investigator
主要研究者

Harry Tagbor

Principal Investigator

Centre for Global Health Research, Ghana

研究点 (1)

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