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OpenTrials
Completed

NCT Number: NCT02700269

Vanderbilt-Zambia Innovations in Global Health Technologies

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.

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Key information

Conditions

Malaria Diagnosis

Age range

6 month–85 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Macha Research Trust

Choma, Zambia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mBEADS

Other

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

Primary outcomes

  1. Enhancement of malaria RDT to detect low levels of P falciparum parasites

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Macha Research Trust, Zambia

Other

Collaborators

  • Fogarty International Center of the National Institute of Health
  • National Institutes of Health (NIH)
  • Vanderbilt University

Registry information

Acronym: VZNIGHT

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Mar 7, 2016
Registry last updated
Feb 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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