Clinical Performance Evaluation of Fyodor Urine Malaria Test (UMT) (NCT01921413) | Clinical Trial Compass
CompletedNot Applicable
Clinical Performance Evaluation of Fyodor Urine Malaria Test (UMT)
Nigeria1,893 participantsStarted 2013-07
Plain-language summary
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.
Who can participate
Age range
2 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
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
* Afebrile
* 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
* Afebrile
* No history of fever within the past 48 hours
* Negative Binax NOW test confirmed by Negative blood smear for clinical malaria
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Accuracy of the UMT for Clinical Malaria Diagnosis
Timeframe: Acute (day 0) fever suspected of being malaria or recent history of fever in the past 48 hours