Low Resource Diagnostics Development Cohort - VZNIGHT — VZN-mBEADS  

Malaria Clinical Trial

Official title: Vanderbilt-Zambia Network for Innovation in Global Health Technology - Malaria mBEADS Diagnostics Development Cohort

Status Active, not recruiting

Clinical Trial Summary

The purpose of these studies is to evaluate the experimental approaches and device designs, in order to improve diagnostic performance of the RDT only. The results from the enhanced RDT methodology will be not be shared with patients or care providers, since they are as of yet, unproven.

Clinical Trial Description

Populations at risk for malaria infection need diagnostic technologies that are reliable and sensitive in settings without electricity, clean water, or highly trained technicians. Macha Research Trust and Zambia Ministry of Health are collaborating to identify and treat low-level and asymptomatic malaria infections and evaluate elimination strategies. The VZNIGHT research program will focus on development of technologies and approaches to facilitate diagnosis and evaluation of asymptomatic malaria using high sensitivity, point of care diagnostic technologies. The diagnostic technologies in development are now sufficiently mature that a transition from laboratory-synthesized samples to primary human specimens collected in the field is necessary to advance their development.

Specific Aim: The investigators will evaluate approaches using magnetic bead capture, isolation, and surface tension valve transfer of biomarkers to improve the sensitivity of already approved RDTs for detection of malaria infection. Results will be compared to those obtained using unenhanced capillary blood specimens directly applied to approved malaria RDTs (the current standard of care).

The purpose of these studies is to evaluate the experimental approaches and device designs in a field setting, in order to improve diagnostic performance of the RDT only. Anonymous, finger-prick blood specimens will be collected from individuals consenting to the study who have been advised to undergo a malaria rapid diagnostic test as part of standard clinical practice or public health surveillance. The results from the enhanced RDT methodology will be not be shared with patients or care providers, since they are as of yet, unproven.

Results from rapid diagnostic tests that are approved for clinical use by international and national governing bodies and that are administered at the same time as part of the typical standard of care, will be shared with study participants by the administering clinician or their representative in the clinical setting. Individuals who test positive for malaria infection using standard RDT methods will receive standard of care treatment administered by an authorized care provider. ;

Related Conditions & MeSH terms

• Malaria

• NCT number: NCT02698774
• Study type: Observational
• Source: Vanderbilt University Medical Center
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2016
• Completion date: August 2018