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临床试验/CTRI/2011/09/002031
CTRI/2011/09/002031已完成4 期

Studies on P.vivax malaria in urban population of Kolkata with special reference to Chloroquine sensitivity and relapse pattern - PVCQ

Department of Health and Family Welfare Govt of West Bengal0 个研究点目标入组 240 人开始时间: 待定最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
240

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • According to WHO Protocol 2009
  • Inclusion criteria
  • age over 6 months
  • mono-infection with P. vivax detected by microscopy
  • asexual parasite count 1000 â?? 1,00,000/µl
  • axillary temperature >= 37.5 °C or history of fever during the 48 h before recruitment
  • ability to swallow oral medication
  • ability and willingness to comply with the protocol for the duration of the study and to comply with the study visit schedule
  • informed consent from the patient or from a parent or guardian in the case of children
  • absence of a clinical condition due to vivax malaria (coma, respiratory distress syndrome or severe anaemia) requiring hospitalization
  • absence of severe malnutrition according to WHO child growth standards
  • absence of a febrile condition due to diseases other than malaria (e.g. measles, acute lower respiratory tract infection, severe diarrhoea with dehydration) or other known underlying chronic or ystemic disease (e.g. cardiac, renal or hepatic disease, HIV/AIDS).
  • absence of regular medication, which might interfere with anti-malarial pharmacokinetics

排除标准

  • Exclusion criteria
  • Presence of one or more of the general danger signs or any sign of severe or complicated malaria
  • Presence of mixed infection
  • Presence of severe malnutrition
  • Presence of febrile conditions caused by diseases other than malaria
  • Presence of a severe disease
  • Contraindication related to anti-malarial drugs used, specially h/o allergy

研究者

发起方
Department of Health and Family Welfare Govt of West Bengal

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