Clinical Validation of Fyodor Urine Malaria Test (UMT)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 1,893
- Locations
- 1
- Primary Endpoint
- Accuracy of the UMT for Clinical Malaria Diagnosis
Study Overview
Brief 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.
Detailed Description
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:
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 2 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •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
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
Outcomes
Primary Outcomes
Accuracy of the UMT for Clinical Malaria Diagnosis
Time Frame: 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.
Secondary Outcomes
- Monitoring the Effectiveness of Malaria Treatment by Rapid Urine Testing(From Day 3 of ACT administration, and followed up weekly for 28 days)