Study Results
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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COMPLETED
190 participants
OBSERVATIONAL
2020-02-01
2021-12-31
Brief Summary
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To address these, multiple organisations have developed next generation microscopes to move towards a next generation microscope that can improve slide preparation, interpretation or data collection, or a combination of these features.
In this study, a prospective evaluation of miLab™ and other next generation automated microscope solutions as well as a malaria rapid diagnostic test (RDT) reader app will be performed in malaria-endemic countries to assess their clinical performance for detection of malaria clinical cases at POC.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Case
Symptomatic patients positive for malaria by PCR
Novel malaria diagnostics & tools
Next generation microscopy tools for malaria diagnosis and medical applications
Control
Symptomatic patients negative for malaria by PCR
Novel malaria diagnostics & tools
Next generation microscopy tools for malaria diagnosis and medical applications
Interventions
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Novel malaria diagnostics & tools
Next generation microscopy tools for malaria diagnosis and medical applications
Eligibility Criteria
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Inclusion Criteria
* Malaria status (positive or negative) established by microscopy at the health facility, where the patient is presenting
* 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 finger prick blood sample at enrollment
Exclusion Criteria
* Presence of symptoms and signs of severe disease and/or central nervous system infections, as defined by WHO guidelines
5 Years
ALL
No
Sponsors
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Foundation for Innovative New Diagnostics, Switzerland
OTHER
Responsible Party
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Locations
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Institute of Endemic Diseases, Medical Campus
Khartoum, , Sudan
Countries
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References
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Hamid MMA, Mohamed AO, Mohammed FO, Elaagip A, Mustafa SA, Elfaki T, Jebreel WMA, Albsheer MM, Dittrich S, Owusu EDA, Yerlikaya S. Diagnostic accuracy of an automated microscope solution (miLab) in detecting malaria parasites in symptomatic patients at point-of-care in Sudan: a case-control study. Malar J. 2024 Jun 28;23(1):200. doi: 10.1186/s12936-024-05029-3.
Other Identifiers
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MA013
Identifier Type: -
Identifier Source: org_study_id
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