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临床试验/NCT02769013
NCT02769013已完成不适用

Assessing the Effect of Neglected Tropical Diseases on Plasmodium Falciparum Transmission in an Area of Co-endemicity

University Hospital Tuebingen2 个研究点 分布在 2 个国家目标入组 380 人开始时间: 2016年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
380
试验地点
2
主要终点
Number of participants with Plasmodium falciparum gametocytes and/or asexual blood stages

研究概览

简要总结

Assessing the effect of neglected tropical diseases on Plasmodium falciparum transmission in an area of co endemicity.

详细描述

The project is divided in three different work packages that cover the life cycle of P. falciparum :

  1. In Work Package 1 (WP1) the investigators will assess whether S. haematobium infection increases the human reservoir of P. falciparum by increasing the carriage rate and incidence of P. falciparum gametocytaemia as well as by increasing the proportion and incidence of subject with sub-microscopic P. falciparum infection. The investigators will also determine whether this increase in gametocyte carriage is a consequence of an impairment of the immune response of helminth infected subjects to P. falciparum.
  2. In Work Package 2 (WP2) the investigators will determine whether the transmission of the sexual forms of P. falciparum from the human host to mosquito is increased in S. haematobium infected subjects compared to uninfected controls. Moreover the investigators will study whether the immunological changes induced in S. haematobium infected subjects lead to a decrease of the transmission reducing activity of IgG specific to Pfs48/45 and Pfs230 (both capable of blocking/impairing further development of P. falciparum in the mosquito gut).
  3. Finally in Work Package 3 (WP3) the investigators will assess whether S. haematobium infection affects the transmission of P. falciparum from the mosquito to the human host. This effect will be determined indirectly by assessing whether S. haematobium infected subjects are more attractive to mosquitoes.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
6 Years 至 30 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects aged from 6 to 30 years
  • Without severe or moderate disease
  • Agreement to be enrolled in the study (written informed consent or consent by the legal representative and assent)
  • Living in the study area for at least 1 year

排除标准

  • Anaemia with haemoglobin less than 8g/dl
  • Know sickle cell disease
  • Macroscopic haematuria
  • Any other know severe disease

结局指标

主要结局

Number of participants with Plasmodium falciparum gametocytes and/or asexual blood stages

时间窗: 15 months

Presence of Plasmodium falciparum gametocytes and/or asexual blood stages will be assessed by a quantitative real-time PCR assay in the blood obtained from participants. Unit of measurements for both parameters is numbers/µl.

次要结局

  • Number of participants with positive serum antibodies specific to the asexual and gametocyte stages of Plasmodium falciparum.(15 months)
  • Percentage of mosquitoes attracted to Schistosoma-infected participants to non-infected individuals in a wind-tunnel assay.(15 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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