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临床试验/CTRI/2018/02/012087
CTRI/2018/02/012087已完成不适用

B cell phenotyping, TLR4 expression determination, anti-parasite antibody profiling of serum samples and epidemiological data collection of patients diagnosed with malaria and comparison with healthy controls and non malarial-fever participants at a tertiary referral centre

Tata Institute of Fundamental Research1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2013年1月8日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
300
试验地点
1
主要终点
Percentage of B cell subsets TLR4 expression and antiparasite antibody profiles on day 1 (main) and day 30 (preferably)

研究概览

简要总结

The immune system is a remarkable defense againstpotentially pathogenic microorganisms B lymphocytes derive fromlymphoid progenitor cells which in turn are derived from hematopoietic stemcells B cell development occurs in thebone marrow and involves the sequential differentiation of stem cells intoproB preB and then immature B cells Animal studies in mouse models of malariahave shown an increase in the immature B cell population Similarly in Kisumucity Kenya which is hyperendemic for malaria children suffering fromfalciparum malaria have a large proportion of immature B cells in theperipheral blood This is relative to normal controls Study of these immaturecells may help in the understanding of the disease pathogenesis The presentstudy will be similar to the one done in Kenya and will evaluate the proportionof immature B cells in peripheral blood of adults and children suffering fromvivax and falciparum malaria The controls will be those with fevers that arenot malaria (smear negative) as also normal healthy participants The presentstudy constitutes basic research and may or may not have an eventual application However it will aid in understanding the pathogenesis of malaria

研究设计

研究类型
Interventional
分配方式
Other
盲法
Not Applicable

入排标准

年龄范围
7.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • Females and males of age 5 and above and upto the age of 70 years with clinically suspected malaria on treatment with antimalarials and/or uncomplicated symptomatic malaria (proven) as indicated by the presence of blood smears positive for P falciparum or P.
  • vivax asexual parastemia Participants (living/working with the malaria patients) of either gender with age more than 18 and upto a maximum of 70 years Participants of either gender with age more than 18 (upto a maximum of 70 yers) and suffering from non- malarial fever Willing to participate in this study and ability to comply with the study protocol.

排除标准

  • Inability to comprehend or unwillingness to follow the study protocol.
  • Complicated malaria patients ( patients with cerebral malaria multiple organ dysfunction severe anemia).

结局指标

主要结局

Percentage of B cell subsets TLR4 expression and antiparasite antibody profiles on day 1 (main) and day 30 (preferably)

时间窗: Blood collection will be done on Day 1 and Day 30

次要结局

未报告次要终点

研究者

申办方类型
Research institution

研究点 (1)

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