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临床试验/NCT04635553
NCT04635553Unknown不适用

Prevalence of Potential Schistosome Hybrids and Their Invasive Capacity Under Praziquantel Pressure in Northern Senegal

Institut de Recherche pour le Developpement1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2020年8月11日最近更新:
适应症
相关药物

试验速览

阶段
不适用
入组人数
250
试验地点
1
主要终点
Change from baseline in prevalence and intensity of schistosome infection

研究概览

简要总结

The overall objective of this project is to examine and quantify the potential existence and impact on Praziquantel (PZQ) efficacy, of naturally occurring S. haematobium and S. bovis hybrid populations in northern Senegal. Schistosome hybrids may present vigor compared to their pure parental forms and hence, may be less sensitive to PZQ. We hypothesise that PZQ repeated treatment selects the hybrid schistosome populations.

详细描述

Human schistosomiasis is a Neglected Tropical Disease caused by schistosome helminth worms with impressive epidemiological statistics associated: 800 million people at risk in 78 countries, > 230 million infected and > 200 000 deaths each year. The disease is highly endemic in sub-Saharan Africa where it persists despite mass drug administration with Praziquantel (PZQ). Some schistosomes are specific to humans and induce two main disease forms (either mesenteric or uro-genital) while others are associated with wild animals. However, hybridization can occur between different schistosome species. In northern Senegal, hybridization between schistosome species specific to humans and animals is now known to be frequent with the potential risk of zoonotic transmission.

This study will propose an integrative approach by conducting parasitological and molecular analysis including, schistosome miracidia genotyping to show if PZQ repeated treatment affects the genomic composition (Frequencies of alleles) of hybrid populations.

The objectives are:

  • Determine the current prevalence of potential hybrid schistosome populations in their natural setting in Senegal
  • Determine the sensitivity of hybrid schistosomes to praziquantel treatment in field populations
  • Determine the molecular basis (at the genome level) of such phenotypic changes).

The study is a longitudinal observation of a cohort of school children after repeated Praziquantel (40 mg/kg) treatment, a drug commonly used through Mass Drug Administration (MDA) to treat schistosomiasis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
5 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children between the initiation courses (CI) and elementary course second year (CE2)
  • Absence of declared chronic pathologies that could impact the follow-up
  • Be positive for S. haematobium infection during the selection period (excreting eggs)
  • Residing in the study area during the 3 years of the follow-up

排除标准

  • Absence of written informed consent or expressed refusal from the child
  • Enrolled in another on going study, which implicates the administration of PZQ or tests another product.

结局指标

主要结局

Change from baseline in prevalence and intensity of schistosome infection

时间窗: December 31. 2020

Determine at the 1 month post treatment the cure rate (CR) of the treatments and Egg Reduction Rates (ERR).

次要结局

  • Hybrids tolerance to praziquantel(December 31, 2021)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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