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临床试验/NCT00513500
NCT00513500已完成不适用

Zambia Integrated Management of Malaria and Pneumonia Study

Boston University1 个研究点 分布在 1 个国家目标入组 3,125 人开始时间: 2007年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
3,125
试验地点
1
主要终点
Number of Children Who Received Early and Appropriate Treatment for Pneumonia.

研究概览

简要总结

The purpose of the study is to demonstrate the effectiveness and feasibility of community-based management of pneumonia and malaria by community health workers (CHWs) in a rural district of Zambia.

详细描述

Pneumonia and malaria are the two leading causes of morbidity and mortality among children under five in sub-Saharan Africa. Due to limited access to health services in many developing countries, a number of global health organizations, including the World Health Organization, have strongly advocated the use of community health workers (CHWs) to deliver basic health care in the community and to facilitate referral to primary health facilities.

Existing supported CHWs in the study area will be trained in the assessment and classification of children between six months and five years of age presenting with fever and/or cough/difficult breathing. In the intervention arm, CHWs will be supplied with rapid diagnostic tests (RDTs), Coartem (a fixed dose combination of artemether-lumefantrine) and amoxicillin. The intervention CHWs will be trained to use RDTs in patients with reported fever and provide those with a positive result with Coartem; and patients suspected of pneumonia (based on fast breathing) will be treated with amoxicillin as per the standard of care at health facilities and monitored. In the control arm, no RDT will be performed. The CHWs will be supplied with Coartem to treat malaria/febrile illness as per the integrated management of childhood illnesses (IMCI) guidelines and patients suspected of pneumonia will be referred to the health facility for treatment as per the current practice. Data collectors will routinely visit CHWs to collect data on their consultations and follow-up patients treated by CHWs in their homes..

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
6 Months 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Age between 6 months and 5 years
  • Present with history of fever or reported fever
  • Present with cough or difficult breathing

排除标准

  • Age below 6 months and above 5 years
  • Presence of signs and symptoms of severe illness

研究组 & 干预措施

1

Experimental

Give one half tablet (20mg artemether, 120mg lumefantrine) to children weighing (5-9.9kg) and one tablet to children weighing (10-20kg) twice a day for three days for malaria based on rapid diagnostic test. For pneumonia, give one half tablet (250mg amoxicillin) for children weighing (5-9.9kg) and one tablet for children weighing (10-20kg) three times a day for five days.

干预措施: Coartem and amoxicillin (Drug)

2

Active Comparator

Give one half tablet (20mg artemether, 120mg lumefantrine) to children weighing (5-9.9kg) and one tablet to children weighing (10-20kg) twice a day for three days for malaria based on clinical diagnosis. For pneumonia, refer to the nearest health facility

干预措施: Coartem (Drug)

结局指标

主要结局

Number of Children Who Received Early and Appropriate Treatment for Pneumonia.

时间窗: one year

Early and appropriate is defined as receiving 13-15 doses of amoxicillin over 5 days and receiving the first dose within 24-48 hours of onset of first symptom

Number of Children With Fever Who Received Coartem (Artemether-lumefantrine)

时间窗: one year

次要结局

  • Number of Children Who do Not Respond to Treatment for Pneumonia(one year)

研究者

申办方类型
Other

研究点 (1)

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