VZNIGHT: Vanderbilt-Zambia Innovations in Global Health Technologies

Sponsor
Macha Research Trust, Zambia (Other)
Overall Status
Completed
CT.gov ID
NCT02700269
Collaborator
Vanderbilt University (Other), National Institutes of Health (NIH) (NIH), Fogarty International Center of the National Institute of Health (NIH)
278
Enrollment
1
Location
34
Actual Duration (Months)
8.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or DiseaseIntervention/TreatmentPhase
  • Other: mBEADS

Study Design

Study Type:
Observational
Actual Enrollment :
278 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Vanderbilt-Zambia Innovations in Global Health Technologies
Actual Study Start Date :
Apr 1, 2016
Actual Primary Completion Date :
Feb 1, 2019
Actual Study Completion Date :
Feb 1, 2019

Outcome Measures

Primary Outcome Measures

  1. Enhancement of malaria RDT to detect low levels of P falciparum parasites [5 years]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Months to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Macha Research TrustChomaZambia

Sponsors and Collaborators

  • Macha Research Trust, Zambia
  • Vanderbilt University
  • National Institutes of Health (NIH)
  • Fogarty International Center of the National Institute of Health

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Macha Research Trust, Zambia
ClinicalTrials.gov Identifier:
NCT02700269
Other Study ID Numbers:
  • MRT15003.2
  • 5D43TW009348
  • NCT02698774
First Posted:
Mar 7, 2016
Last Update Posted:
Feb 19, 2020
Last Verified:
Feb 1, 2020
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 19, 2020