Automated Microscopy Evaluation Study

Malaria Clinical Trial

— AutoMic  

Official title:

Clinical Evaluation of Automated Microscope Solutions for Malaria Diagnosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04558515
• Other study ID #: MA013
• Status: Completed
• Start date: February 1, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: November 2023
• Source: Foundation for Innovative New Diagnostics, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Since the introduction of Giemsa stain in 1904 until today, malaria microscopy has been the standard of practice for malaria diagnosis. However, microscopic detection of malaria parasites is labour-intensive, time-consuming and expertise-demanding. Moreover, the slide interpretation is highly dependent on the staining technique and the technician's expertise. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: December 31, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years and older

Eligibility

Inclusion Criteria:

• Aged 5 years or older
• 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:

• Having received antimalarial treatment during the preceding four-week period
• Presence of symptoms and signs of severe disease and/or central nervous system infections, as defined by WHO guidelines

Related Conditions & MeSH terms

• Malaria

Intervention

Diagnostic Test:
• Novel malaria diagnostics & tools
Next generation microscopy tools for malaria diagnosis and medical applications

Locations

Country	Name	City	State
Sudan	Institute of Endemic Diseases, Medical Campus	Khartoum

Sponsors (1)

Lead Sponsor	Collaborator
Foundation for Innovative New Diagnostics, Switzerland

Country where clinical trial is conducted

Sudan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical performance assessment	Point estimates of clinical performance characteristics with 95% confidence intervals (sensitivity, specificity) of next generation microscopy tools using nPCR as the reference test for the detection of malaria clinical cases	up to 6 months
Primary	Concordance	Point estimate with 95% confidence intervals of the percentage agreement in interpreting malaria diagnostics between the app and visual reading	up to 6 months