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临床试验/NCT06153862
NCT06153862进行中(未招募)不适用

Africa Ready Malaria Screening

University of Ghana2 个研究点 分布在 1 个国家目标入组 1,640 人开始时间: 2022年9月23日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
1,640
试验地点
2
主要终点
MSP1-19 malaria antigen

研究概览

简要总结

This study aims to develop immuno-analytical assays for testing the titres of malaria antibodies in Ghanaian patients' and/or donors' sera using a recombinantly produced MSP119 fusion protein and/or MSP119-derived synthetic peptides as antigens.

详细描述

In this study, immuno-analytical assays will be developed for determining the titres of malaria antibodies in sera of two groups (malaria patients and donors/healthy volunteers) using a recombinantly produced MSP119 fusion protein and/or MSP119-derived synthetic peptides as antigens. Individuals in the two groups presenting to Shai-Osudoku District hospital will be screened for signs and symptoms of malaria according to the WHO criteria. Those within the inclusion and exclusion criteria will be introduced to the study through informed consent for adults (18 years and over) or parents/guardians for children below 12 years and assent for adolescents between 12 and below 18 years, along with informed consent from their parents. Enrolled study participants' demographic data and vital signs will be captured electronically onto the CRF. Patients will have their clinical history and detailed physical examination done by the study clinicians and then be sent to the laboratory for investigations to confirm the malaria diagnosis. The results of patients will be communicated to the study clinician to commence the appropriate treatment. At the of the study, the results of all assays will be analyzed to determine if this test can be used to diagnose malaria infection.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients with confirmed malaria (uncomplicated and complicated cases) are diagnosed by the national guidelines.
  • Healthy individuals without confirmed malaria per the national guidelines.
  • Adults and parents or guardians of children below 12 years willing to participate based on signed informed consent.
  • Willing to give assent to adolescents between the ages of 12 and below 18 years.
  • Willing to give a blood sample for the necessary investigations as explained in the informed consent.
  • Willing to adhere to study procedures and a follow-up visit at the clinic, hospital, or health facility.

排除标准

  • Anyone refusing informed consent (or assent for adolescents) to be part of the study.
  • Refusal to study procedures or giving of sample for the necessary investigations.

结局指标

主要结局

MSP1-19 malaria antigen

时间窗: one year

Number of participants with MSP1-19 malaria antigen as assessed by a lateral flow test kit.

次要结局

  • Anti-MSP1-19 malaria antibody(three years)

研究者

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

Prof. Kwabena F.M. Opuni

Associate Professor

University of Ghana

研究点 (2)

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