Malaria Clinical Trial
— EasyScanGoOfficial title:
A Multi-Centric Evaluation of a Device for Automated Malaria Microscopy (EasyScan Go)
NCT number | NCT03512678 |
Other study ID # | MAL18002 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 25, 2018 |
Est. completion date | June 30, 2020 |
Verified date | September 2020 |
Source | University of Oxford |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 2250 |
Est. completion date | June 30, 2020 |
Est. primary completion date | October 31, 2019 |
Accepts healthy volunteers | |
Gender | All |
Age group | 6 Months to 75 Years |
Eligibility |
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 ÂșC) 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 |
Country | Name | City | State |
---|---|---|---|
Thailand | Shoklo Malaria Research Unit | Mae Sot | Tak |
Lead Sponsor | Collaborator |
---|---|
University of Oxford |
Thailand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diagnostic sensitivity for malaria parasite detection | 6 months | ||
Primary | Diagnostic specificity for malaria parasite detection | 6 months | ||
Primary | Kappa statistic for parasite species identification | 6 months | ||
Primary | Bland-Altman plots for parasite density estimation | 6 months | ||
Secondary | Reliability (comparison between 2 devices and repeat reads) | 6 months | ||
Secondary | Cost-effectiveness as compared with routine methods | 6 months | ||
Secondary | Prevalence of parasite genetic markers of resistance to antimalarials by location and time period | 6 months | ||
Secondary | Prevalence of parasites carrying deletions of pfhrp2/3 genes by location and time period | 6 months |
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