NCT02700269

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
278

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 25, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 7, 2016

Completed
25 days until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

February 19, 2020

Status Verified

February 1, 2020

Enrollment Period

2.8 years

First QC Date

February 25, 2016

Last Update Submit

February 18, 2020

Conditions

Malaria Diagnosis

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

mBEADSOTHER

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

Eligibility Criteria

Age6 Months - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Those seeking care for suspected malaria in Zambia

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Macha Research Trust

Choma, Zambia

Location

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2016

First Posted

March 7, 2016

Study Start

April 1, 2016

Primary Completion

February 1, 2019

Study Completion

February 1, 2019

Last Updated

February 19, 2020

Record last verified: 2020-02

Locations

ZA(1)