Clinical Performance Evaluation of Fyodor Urine Malaria Test (UMT)

NCT01921413 | Completed DMC

• 1 other identifier: UMT Evaluation
• Study Type: observational
• Target: 1,893
• Locations: 1 country
• Sites: 1

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.

Conditions

Malaria

Keywords

Plasmodium falciparum; Clinical Malaria; Fever; Schistosoma hematobium; Rheumatoid arthritis

Outcome Measures

Primary Outcomes (1)

• Accuracy of the UMT for Clinical Malaria Diagnosis

  • Establish sensitivity and specificity of the UMT for malaria diagnosis in febrile patients.

  Acute (day 0) fever suspected of being malaria or recent history of fever in the past 48 hours

Secondary Outcomes (1)

• Monitoring the Effectiveness of Malaria Treatment by Rapid Urine Testing

  From Day 3 of ACT administration, and followed up weekly for 28 days

Interventions

Urine Malaria Test DEVICE

Rapid non-invasive malaria diagnostic test

Also known as: UMT

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Fyodor Biotechnologies Inc: lead
• University of Lagos, Nigeria: collaborator
• Johns Hopkins University: collaborator
• Federal Ministry of Health, Nigeria: collaborator
• Duke University: collaborator

Study Sites (1)

College of Medicine of the University of Lagos

Idi Araba, Lagos, Nigeria

Location

Related Publications (3)

• Adebajo AO, Cawston TE, Hazleman BL. Rheumatoid factors in association with rheumatoid arthritis and infectious diseases in West Africans. J Rheumatol. 1994 May;21(5):968-9. No abstract available.

  PMID: 8064747 BACKGROUND

• Tighe H, Warnatz K, Brinson D, Corr M, Weigle WO, Baird SM, Carson DA. Peripheral deletion of rheumatoid factor B cells after abortive activation by IgG. Proc Natl Acad Sci U S A. 1997 Jan 21;94(2):646-51. doi: 10.1073/pnas.94.2.646.

  PMID: 9012838 BACKGROUND

• Lehman JS Jr, Mott KE, De Souza CA, Leboreiro O, Muniz TM. The association of Schistosomiasis mansoni and proteinuria in an endemic area. A preliminary report. Am J Trop Med Hyg. 1975 Jul;24(4):616-8. doi: 10.4269/ajtmh.1975.24.616.

  PMID: 1155697 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine

MeSH Terms

Conditions

Malaria; Malaria, Falciparum; Fever; Schistosomiasis haematobia; Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Schistosomiasis; Trematode Infections; Helminthiasis; Urinary Tract Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 7, 2013
• First Posted: August 13, 2013
• Study Start: July 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: April 22, 2014

Record last verified: 2014-04

Locations

NG (1)