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临床试验/NCT05058885
NCT05058885招募中不适用

Plasmodium Vivax Burden, Range and Transmission Among Duffy Negative Inhabitants in Cameroon.

University of Dschang1 个研究点 分布在 1 个国家目标入组 900 人开始时间: 2022年5月2日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
900
试验地点
1
主要终点
Proportion of P. vivax exposed patients in different eco-climatic settings in Cameroon

研究概览

简要总结

Although Plasmodium vivax (P. vivax), one of the five malaria species causing parasites, has the widest geographical distribution, it is rare in sub-Saharan Africa due to the absence of a red blood cell receptor (Duffy antigen) in black Africans. Duffy-negative individuals are, for the most part, therefore refractory to P. vivax infection and the Duffy-negative phenotype is found at highest frequencies in Africa, whereas it is relatively rare elsewhere. P. vivax has however, been observed as single infections in up to 5% of Duffy-negative febrile patients in one health facility in Dschang, a region of low malaria transmission in Western highlands of Cameroon. Whereas in the littoral South West and Southern forest of Cameroon characterised by high malaria transmission, areas, there are contrasting molecular evidence of human P. vivax infection. While important, the significance is limited from an epidemiological point of view, concerning the source, transmission, distribution range of P. vivax. There is thus a challenge in the true estimation of malaria burden, as well as the attributable parasite species in infections occurring in the low transmission areas of Western Cameroon. As a consequence, our understanding of the local epidemiology of malaria in Western Cameroon warrants formal investigation. The current proposal is a multi-centre observational study. Its purpose is to characterise the malaria species composition and particularly exposure and burden of P. vivax across malaria endemic settings in Cameroon. It will use multiplex serological methods based on quantitative suspension array on finger-stick blood samples collected from febrile patients of ages 1-100 during two malaria transmission seasons in different eco-climatic regions in Cameroon.

详细描述

Type of study:

The current proposal is a multi-centre observational study in different eco-climatic regions in Cameroon.

Study locations:

Dschang health district(Low transmission, highland) , Maroua (Sahel, high transmission) and Bertoua-Batouri (East region, forest, perennial transmission).

Study period:

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
1 Year 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient must be febrile (temperature >37.50 C or history of fever within 24 hours of arrival to the hospital)
  • Patient must be aged 1 year or older
  • Both males and females alike
  • The patient must be able to sign a consent/assent form
  • The patient must be seeking care and be suspected of malaria infection

排除标准

  • Eligible patient who refuses consent to study procedures
  • Patient withdraws consent before or during the start of study procedures
  • Patient, who, for any reason, refuses that sensitive data should not be processed.

结局指标

主要结局

Proportion of P. vivax exposed patients in different eco-climatic settings in Cameroon

时间窗: June 2022-June 2023

A cut-off for seropositivity will be determined based on the mean of log MFI values plus three standard deviations of the seronegative controls. Separate cut-off values will be generated for each of the studied antigens. By so doing, participants will be classified as seropositive or seronegative depending on whether their antibody levels lie above or below the cut-off values. The seroprevalence will be calculated for each antigen, as the proportion of seropositive individuals of the total study population, per study site, and overall.

Species ratio among febrile patients infected with Plasmodium spp in geo-ecological regions of Cameroon.

时间窗: June 2022-June 2023

This will be defined as the ratio of each of identified species by serology to the total species observed for the particular region and, if required, for the overall study sites.

次要结局

  • Entomological innoculation rate of vivax mosquitoes(June 2022-December, 2023.)
  • Vector type, abundance, infectivity and anthropophily(June 2022-December, 2023.)

研究者

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

Dr Innocent Ali

Senior Lecturer

University of Dschang

研究点 (1)

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