Automated Microscopy Evaluation Study (AutoMic)

November 15, 2023 updated by: Foundation for Innovative New Diagnostics, Switzerland

Clinical Evaluation of Automated Microscope Solutions for Malaria Diagnosis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

190

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sudan
      • Khartoum, Sudan
        • Institute of Endemic Diseases, Medical Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with symptoms suggestive of malaria seeking clinical care in health facilities

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Case
Symptomatic patients positive for malaria by PCR
Diagnostic test: Novel malaria diagnostics & tools
Next generation microscopy tools for malaria diagnosis and medical applications
Control
Symptomatic patients negative for malaria by PCR
Diagnostic test: Novel malaria diagnostics & tools
Next generation microscopy tools for malaria diagnosis and medical applications

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical performance assessment
Time Frame: up to 6 months
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
Concordance
Time Frame: up to 6 months
Point estimate with 95% confidence intervals of the percentage agreement in interpreting malaria diagnostics between the app and visual reading
up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Foundation for Innovative New Diagnostics, Switzerland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2020

Primary Completion (Actual)

July 1, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

September 15, 2020

First Submitted That Met QC Criteria

September 21, 2020

First Posted (Actual)

September 22, 2020

Study Record Updates

Last Update Posted (Estimated)

November 17, 2023

Last Update Submitted That Met QC Criteria

November 15, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MA013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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