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Clinical Performance Evaluation of Fyodor Urine Malaria Test (UMT)

NCT01921413 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1893

Last updated 2014-04-22

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Urine Malaria Test

Rapid non-invasive malaria diagnostic test

Sponsors & Collaborators

  • University of Lagos, Nigeria

    collaborator OTHER

  • Johns Hopkins University

    collaborator OTHER

  • Federal Ministry of Health, Nigeria

    collaborator OTHER_GOV

  • Duke University

    collaborator OTHER

  • Fyodor Biotechnologies Inc

    lead INDUSTRY

Principal Investigators

  • Wellington A Oyibo, PhD · ANDI Centre of Excellence for Malaria Diagnosis, International Malaria Microscopy Training & RDT QA Center, & WHO/TDR/FIND Malaria Specimen Bank Site, Department of Medical Microbiology & Parasitology, College of Medicine, University of Lagos, Nigeria

  • William (Bill) Brieger, DrPH · Johns Hopkins University, Bloomberg School of Public Health, Baltimore, Maryland, USA

  • Wendy O'Meara, PhD · Duke University School of Medicine, Durham, North Carolina, USA

  • Nnenna Ezeigwe, MBBS, FMCPH · Coordinator, National Malaria Control Program/Federal Ministry of Health, Abuja, Nigeria

  • Godwin Ntadom, MBBS, MPH · Head, Case Management, National Malaria Control Program/Federal Ministry of Health, Abuja, Nigeria

Eligibility

Min Age
2 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • Nigeria

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01921413 on ClinicalTrials.gov