Clinical Validation of Fyodor Urine Malaria Test (UMT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,893
- 试验地点
- 1
- 主要终点
- Accuracy of the UMT for Clinical Malaria Diagnosis
研究概览
简要总结
The purpose of this study is to evaluate the clinical performance of the one-step Fyodor Urine Malaria Test (UMT), to determine its accuracy (sensitivity and specificity) for the diagnosis of Plasmodium falciparum malaria in febrile patients. A total of 1500 properly consented children and adults presenting with fever (axillary temperature ≥37.5°C) or history of fever in the last 48 hours (Group 1), 250 apparently "healthy" individuals (Control, Group 2), and 50 patients with Schistosoma hematobium and Rheumatoid arthritis (Group 3), will be recruited. Matched urine and fingerprick (capillary) blood samples will be collected and tested using the UMT and, Binax NOW® malaria rapid diagnostic test (blood test) and thick smear microscopy, respectively. The overall agreement of the UMT results to the Binax NOW analysis and thick smear microscopy will be used to establish UMT sensitivity and specificity.
详细描述
Primary Objective:
To evaluate the clinical performance (sensitivity and specificity) of Fyodor UMT for detecting Plasmodium falciparum malaria in febrile patients.
Secondary Objectives:
- To monitor time-to-clearance of the cognate parasite protein from patient urine
- To assess the potential effects of proteinuria, inflammation and anti-fever medications on Fyodor UMT performance
- To determine UMT performance when used for asymptomatic (afebrile) individuals, who may be carriers of the parasite.
Study Design:
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
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Group 1 - Febrile Patients:
- •Age: two years or older
- •Fever at the time of presentation (axillary temperature ≥37.5°C), or history of fever within the past 48 hours
- •Subjects with concurrent illnesses not listed in the exclusion criteria will be evaluated and treated for these illnesses and included in the study
- •Written informed consent obtained from the participant or parent/guardian
- •Group 2 - Apparently Healthy Individuals:
- •Children 2 years or older, as well as adults of both genders
- •No history of fever within the past 48 hours
- •Negative Binax NOW test confirmed by Negative blood smear for clinical malaria
- •Group 3 - Patients with unrelated medical conditions known to elicit proteinuria in patients:
- •Children 2 years or older, as well as adults
- •No history of fever within the past 48 hours
- •Negative Binax NOW test confirmed by Negative blood smear for clinical malaria
排除标准
- •Pregnancy
- •Patients with respiratory distress, diffuse bleeding, recent seizures, coma, inability to drink, persistent vomiting, or prostration
- •Chronic use of a medication (such as trimethoprim-sulfamethoxazole for preventing AIDS-associated opportunistic infections) with known antimalarial activity
- •Any condition that in the opinion of the Principal Investigator would jeopardize the safety or rights of a participant in the trial or would render the participant unable to comply with the protocol
结局指标
主要结局
Accuracy of the UMT for Clinical Malaria Diagnosis
时间窗: Acute (day 0) fever suspected of being malaria or recent history of fever in the past 48 hours
• Establish sensitivity and specificity of the UMT for malaria diagnosis in febrile patients.
次要结局
- Monitoring the Effectiveness of Malaria Treatment by Rapid Urine Testing(From Day 3 of ACT administration, and followed up weekly for 28 days)