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Evaluation of a Digital Microscope for Malaria (EasyScanGo)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03512678
Recruitment Status : Completed
First Posted : May 1, 2018
Last Update Posted : September 3, 2020
Sponsor:
Information provided by (Responsible Party):
University of Oxford

Brief Summary:

Light microscopy, which is based on century-old technology, remains a key indicator in drug efficacy testing performed in the context of clinical trials for monitoring existing antimalarial drugs or in the context of regulatory clinical trials for registration of new drugs. It is one of the main diagnostic methods for malaria diagnosis in general, as in an ideal setting it can provide low-cost accurate diagnosis, determine the density of parasites in the blood, and accurately differentiate between different malaria parasite species, characteristics vital to the implementation of global plans for drug efficacy monitoring. Malaria rapid tests (RDTs), while useful for rapid diagnosis and case management, do not provide information on the parasite density nor the species differentiation necessary for research and drug efficacy assessment. Microscopy therefore retains key advantages over a number of newer technologies, but its reliability is severely impeded by dependence on high technical competence of the human operators as well as availability of high quality equipment and reagents. Recent studies have demonstrated frequent poor specificity and sensitivity associated with manual microscopy diagnostics in operational conditions. These drawbacks constitute a major limiting factor to effective monitoring and preservation of vital anti-malarial medicines.

Advances in digital microscopy performance and affordability have now opened the door to potentially significant improvements in the performance of malaria microscopy, overcoming serious deficiencies in current drug efficacy assessment, and more broadly in malaria diagnosis and management. Global Good (GG)/Intellectual Ventures Laboratory (IVL) sponsored by the Global Good Fund, has developed a microscope prototype consisting of low cost components to scan and capture images from Giemsa-stained thick blood films on slides. The captured images are analyzed with custom image analysis software developed at GG/IVL, using algorithms that are designed for automatic malaria diagnosis, without user input. Versions of a prototype of the device were first tested in field settings in Thailand in 2014-2015 at clinics operated by the Shoklo Malaria Research Unit (SMRU) and then again in 2016-2017. When compared to expert microscopy at SMRU, the performance of the device with respect to diagnostic sensitivity (87.8%), species identification (85.6% species correctly identified) and parasite density estimation (44% of estimates within +/-25% of reference microscopy result) corresponded to WHO Competence Level 2. The device and the accompanying image analysis algorithms have since been further developed and a new, third version of the prototype is now available for testing in diverse settings with varying malaria prevalence and user expertise.


Condition or disease
Malaria

Detailed Description:

The primary purpose of this evaluation is to quantify the diagnostic performance of the EasyScan Go prototype in various field settings. The performance of the EasyScan Go prototype will be assessed by scanning of negative and positive slides with the EasyScan Go and comparing the results with expert microscopy. Plasmodium genus- and species-specific PCR will also be performed on samples collected at some sites as an additional confirmatory test for the detection of malaria parasites and their species if present. Testing by microscopy and EasyScan Go will be performed in field clinic settings on Giemsa-stained slides prepared from febrile patient blood collected from a finger-prick. Further work will be undertaken at the WWARN laboratory in Bangkok for data analyses and for quality assurance.

Funder: Intellectual Ventures Lab/Global Good (2018) Sponser: University of Oxford Grant refernce number:The Global Good Fund I, LLC PA No.5

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Study Type : Observational
Actual Enrollment : 2250 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Multi-Centric Evaluation of a Device for Automated Malaria Microscopy (EasyScan Go)
Actual Study Start Date : June 25, 2018
Actual Primary Completion Date : October 31, 2019
Actual Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria




Primary Outcome Measures :
  1. Diagnostic sensitivity for malaria parasite detection [ Time Frame: 6 months ]
  2. Diagnostic specificity for malaria parasite detection [ Time Frame: 6 months ]
  3. Kappa statistic for parasite species identification [ Time Frame: 6 months ]
  4. Bland-Altman plots for parasite density estimation [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Reliability (comparison between 2 devices and repeat reads) [ Time Frame: 6 months ]
  2. Cost-effectiveness as compared with routine methods [ Time Frame: 6 months ]
  3. Prevalence of parasite genetic markers of resistance to antimalarials by location and time period [ Time Frame: 6 months ]
  4. Prevalence of parasites carrying deletions of pfhrp2/3 genes by location and time period [ Time Frame: 6 months ]

Biospecimen Retention:   Samples Without DNA
Blood collection from finger-prick (maximum 150-200 µL), which will be used to prepare slides.


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population

The multi-centric evaluation is currently planned for implementation at relatively few sites/countries and the primary criteria for the selection of sites will be based on operational feasibility of the project, i.e., availability of resources to perform the study procedures, adequate expected numbers of malaria positive cases, etc.

Potential sites in Senegal, Kenya, Tanzania, Uganda, Congo, South Africa, Burkina Faso, Brazil, Thailand, Indonesia, Bangladesh, Myanmar and Cambodia are being considered for the study.

A minimum of 80 malaria cases confirmed by expert microscopy and a minimum of 80 malaria-negative cases per study site.

Criteria

Inclusion Criteria:

  • Male or female subjects, age ≥ 6 months to 75 years
  • Febrile at presentation or history of fever in the past 48 hours (≥ 37.5 ºC) and no other obvious diagnosis or cause for fever, warranting malaria investigation under routine clinical practice.
  • Individual informed assent/consent obtained

Exclusion Criteria:

- Signs of severe malaria as defined by WHO


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03512678


Locations
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Thailand
Shoklo Malaria Research Unit
Mae Sot, Tak, Thailand
Sponsors and Collaborators
University of Oxford
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT03512678    
Other Study ID Numbers: MAL18002
First Posted: May 1, 2018    Key Record Dates
Last Update Posted: September 3, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Malaria
Protozoan Infections
Parasitic Diseases
Infections
Vector Borne Diseases