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临床试验/NCT01389557
NCT01389557已完成4 期

Evaluation of Impact Dihydroartemisinin-piperaquine Plus Primaquine on Malaria Transmission in Lempasing Village, Lampung Province, Southern Sumatra

Indonesia University1 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2011年2月1日最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
77
试验地点
1
主要终点
Presence of malaria (P. falciparum and P. vivax) parasites in blood spot

研究概览

简要总结

Artemisinin-based combination therapy (ACT) has been known to be controversial for stopping malaria transmission. The addition of primaquine (PQ) - the only drug commercially available that kills mature transmission stage - to such treatments might be necessary to eliminate this stage. A study is conducted to evaluate the efficacy of dihydroartemisinin-piperaquine (DHP) regimens with PQ on malaria transmission on a community wide level in Lempasing, Lampung, Sumatra.

详细描述

A mass screening baseline survey enabled the description of malaria prevalence (P. falciparum and P. vivax). Malaria infected asymptomatic (from the mass screening) and symptomatic (malaria infected people attending the health center) people were enrolled in the study. Enrolled malaria infected subjects were treated with DHP and PQ according to the treatment regimen. The community was mass screened for malaria infections every 3 months and an incidence cohort screened every month for infections. The 3 aims were to look at malaria antibodies, haemoglobin levels and the incidence of malaria before and after the drug intervention.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
Single (Participant)

入排标准

性别
All
接受健康志愿者

入选标准

  • All individuals residing Lempasing village, kecamatan Hanura, Lampung province during study period

排除标准

  • Individuals with severe or chronic disease (liver, kidney), infant and pregnant or breastfeeding woman
  • Individuals that refuse to sign informed consent are excluded.
  • normal glucose-6-phosphate dehydrogenase enzyme level based on qualitative test (Trinity Biotech® no 203, USA)
  • willingness to sign the informed-consent form

结局指标

主要结局

Presence of malaria (P. falciparum and P. vivax) parasites in blood spot

时间窗: 6 months

Finger prick blood samples are collected for malaria blood smear. Thick and thin blood smears were stained with 3% Giemsa solution for 40 minutes and were read under binocular microscope with 1,000X magnification.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Inge Sutanto

DR Inge Sutanto MPHil, Department of Parasitology, Faculty of Medicine

Indonesia University

研究点 (1)

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