Low Resource Diagnostics Development Cohort - VZNIGHT

Malaria Clinical Trial

— VZN-mBEADS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02698774
• Other study ID #: 130684
• Status: Active, not recruiting
• Phase: N/A
• First received: February 25, 2016
• Last updated: April 18, 2017
• Start date: October 2016
• Est. completion date: August 2018

Study information

• Verified date: April 2017
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: August 2018
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

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

Intervention

Other:
• No Intervention / Not Applicable
Not Applicable. No interventions will be tested in this study. Blood specimens will be collected for laboratory evaluation. No information will be shared with clinical providers or no clinical decisions will be based on information generated from collected specimens.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University	Macha Research Trust, Zambia

References & Publications (2)

Davis KM, Gibson LE, Haselton FR, Wright DW. Simple sample processing enhances malaria rapid diagnostic test performance. Analyst. 2014 Jun 21;139(12):3026-31. doi: 10.1039/c4an00338a. Epub 2014 May 1. — View Citation

Davis KM, Swartz JD, Haselton FR, Wright DW. Low-resource method for extracting the malarial biomarker histidine-rich protein II to enhance diagnostic test performance. Anal Chem. 2012 Jul 17;84(14):6136-42. doi: 10.1021/ac301030m. Epub 2012 Jun 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of histidine rich protein II concentration in blood (pg protein per ml of whole blood)	The investigators will collect blood specimens and use experimental rapid and ELISA-based approaches to evaluate the concentration of malaria parasites using the biomarker protein histidine rich protein II.	Single time point assessment <6 hours after the time of blood collection