Status:
COMPLETED
Clinical Performance Evaluation of Fyodor Urine Malaria Test (UMT)
Lead Sponsor:
Fyodor Biotechnologies Inc
Collaborating Sponsors:
University of Lagos, Nigeria
Johns Hopkins University
Conditions:
Malaria
Eligibility:
All Genders
2+ years
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 Plasmodi...
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 monit...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2014
Estimated Enrollment :
1893 Patients enrolled
Trial Details
Trial ID
NCT01921413
Start Date
July 1 2013
End Date
February 1 2014
Last Update
April 22 2014
Active Locations (1)
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1
College of Medicine of the University of Lagos
Idi Araba, Lagos, Nigeria