ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical Performance Evaluation of Fyodor Urine Malaria Test (UMT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01921413
Recruitment Status : Completed
First Posted : August 13, 2013
Last Update Posted : April 22, 2014
Sponsor:
Collaborators:
University of Lagos, Nigeria
Johns Hopkins University
Federal Ministry of Health, Nigeria
Duke University
Information provided by (Responsible Party):
Fyodor Biotechnologies Inc

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.

Condition or disease Intervention/treatment
Malaria Device: Urine Malaria Test

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 1893 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Clinical Validation of Fyodor Urine Malaria Test (UMT)
Study Start Date : July 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : February 2014

Resource links provided by the National Library of Medicine



Intervention Details:
  • Device: Urine Malaria Test
    Rapid non-invasive malaria diagnostic test
    Other Name: UMT


Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Monitoring the Effectiveness of Malaria Treatment by Rapid Urine Testing [ Time Frame: From Day 3 of ACT administration, and followed up weekly for 28 days ]
    • Determine how quickly the cognate malaria antigens are cleared from patient urine after the prescribed three-day course of artemisinin-combination therapy (ACT);
    • Negative UMT results (as confirmed by microscopy during the study) will establish the effectiveness of malaria treatment and provide a means to rapidly monitor effective treatment;
    • Establish broader UMT utility for epidemiological monitoring in asymptomatic (afebrile) individuals.


Biospecimen Retention:   Samples Without DNA
Urine


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Study population will comprise of individuals 2 years or older of both genders with fever (axillary temperature ≥37.5°C) (Group 1), apparently "healthy" individuals (Control, Group 2), and patients positive for Rheumatoid factor (Group 3), will be recruited will be recruited at primary healthcare facilities across four local government areas in Lagos State, southwest Nigeria - Ikorodu, Surulere, Shomolu and Ibeju-Lekki. The sampling for Schistosomiasis will be carried out in Imalodo and Abuletutu communities in Abeokuta-North Local Government Area of Ogun State, also in southwest Nigeria.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01921413


Locations
Nigeria
College of Medicine of the University of Lagos
Idi-Araba, Lagos, Nigeria
Sponsors and Collaborators
Fyodor Biotechnologies Inc
University of Lagos, Nigeria
Johns Hopkins University
Federal Ministry of Health, Nigeria
Duke University
Investigators
Principal Investigator: 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
Study Director: William (Bill) Brieger, DrPH Johns Hopkins University, Bloomberg School of Public Health, Baltimore, Maryland, USA
Study Director: Wendy O'Meara, PhD Duke University School of Medicine, Durham, North Carolina, USA
Study Director: Nnenna Ezeigwe, MBBS, FMCPH Coordinator, National Malaria Control Program/Federal Ministry of Health, Abuja, Nigeria
Study Director: Godwin Ntadom, MBBS, MPH Head, Case Management, National Malaria Control Program/Federal Ministry of Health, Abuja, Nigeria