Innovation Platform

NCT ID: NCT04558528

Last Updated: 2023-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

640 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-01

Study Completion Date

2021-07-31

Brief Summary

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In this study, a prospective evaluation of novel malaria diagnostic tools under development will be performed in malaria-endemic countries to assess their clinical performance for detection of malaria at point-of-care (POC). This study aims to support product development efforts and aims to provide early stage (TLR\~5) technology developers with valuable information on performance and basic feasibility data that can help to accelerate development.

Detailed Description

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Conditions

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Malaria

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Novel in vitro diagnostics and medical applications

Novel in vitro diagnostics and medical applications

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Aged 5 years or older
* Presenting at the study site with symptoms and signs suggestive of malaria
* Freely agreeing to participate by signing an informed consent form (adults aged 18 and older and parent/legal guardian of a child) and providing assent (children aged 13-17)
* Willing to provide sample at enrolment

Exclusion Criteria

* Presence of symptoms and signs of severe disease and/or central nervous system infections, as defined by WHO guidelines
Minimum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Foundation for Innovative New Diagnostics, Switzerland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Eijkman Institute for Molecular Biology

Jakarta, , Indonesia

Site Status

Stansile

Kigali, , Rwanda

Site Status

Countries

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Indonesia Rwanda

Other Identifiers

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MA014

Identifier Type: -

Identifier Source: org_study_id

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