Vanderbilt-Zambia Innovations in Global Health Technologies

Malaria Diagnosis Clinical Trial

— VZNIGHT  

Official title:

Vanderbilt-Zambia Innovations in Global Health Technologies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02700269
• Other study ID #: MRT15003.2
• Secondary ID: 5D43TW009348
• Status: Completed
• Start date: April 2016
• Est. completion date: February 2019

Study information

• Verified date: February 2020
• Source: Macha Research Trust, Zambia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Investigators will evaluate approaches using magnetic bead capture, isolation, and surface tension valve transfer of biomarkers to process capillary blood in order to improve the sensitivity of already approved Rapid Diagnostic Tests (RDTs) for detection of human malaria infection. Results will be compared to those obtained using unenhanced capillary blood specimens directly applied to approved malaria RDTs. Participants seeking care for possible malaria in Zambia will be recruited to enroll in the study.

Other known NCT identifiers

• NCT02698774

Recruitment information / eligibility

• Status: Completed
• Enrollment: 278
• Est. completion date: February 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 85 Years

Eligibility

Inclusion Criteria:

• Individuals giving written informed consent for themselves

• Children under the age of 18 for whom a parent or guardian can give consent

• Individuals seeking care or treatment of suspected or possible malaria

• Individuals being screened as a contact of someone with recent malaria

• Other individuals willing to have their blood tested for malaria

Exclusion Criteria:

• Anyone over 18 unwilling or unable to provide informed consent

• Anyone under 18 who does not have a parent or guardian to give consent

• Anyone between the age of 12 and 18 who does not give assent

Related Conditions & MeSH terms

• Malaria
• Malaria Diagnosis

Intervention

Other:
• mBEADS
Evaluate approaches using magnetic bead capture, isolation, and surface tension valve transfer of biomarkers to improve the sensitivity of already approved malaria RDTs.

Locations

Country	Name	City	State
Zambia	Macha Research Trust	Choma

Sponsors (4)

Lead Sponsor	Collaborator
Macha Research Trust, Zambia	John E. Fogarty International Center (FIC), National Institutes of Health (NIH), Vanderbilt University

Country where clinical trial is conducted

Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enhancement of malaria RDT to detect low levels of P falciparum parasites	The expected outcome of this research project is to enhance the ability of standard malaria RDTs to detect low levels of Plasmodium falciparum malaria in human capillary blood.	5 years