- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT03512678
Evaluation of a Digital Microscope for Malaria (EasyScanGo)
A Multi-Centric Evaluation of a Device for Automated Malaria Microscopy (EasyScan Go)
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.
Přehled studie
Postavení
Podmínky
Detailní popis
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
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
-
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Tak
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Mae Sot, Tak, Thajsko
- Shoklo Malaria Research Unit
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
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.
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
---|---|
Diagnostic sensitivity for malaria parasite detection
Časové okno: 6 months
|
6 months
|
Diagnostic specificity for malaria parasite detection
Časové okno: 6 months
|
6 months
|
Bland-Altman plots for parasite density estimation
Časové okno: 6 months
|
6 months
|
Kappa statistic for parasite species identification
Časové okno: 6 months
|
6 months
|
Sekundární výstupní opatření
Měření výsledku |
Časové okno |
---|---|
Reliability (comparison between 2 devices and repeat reads)
Časové okno: 6 months
|
6 months
|
Cost-effectiveness as compared with routine methods
Časové okno: 6 months
|
6 months
|
Prevalence of parasite genetic markers of resistance to antimalarials by location and time period
Časové okno: 6 months
|
6 months
|
Prevalence of parasites carrying deletions of pfhrp2/3 genes by location and time period
Časové okno: 6 months
|
6 months
|
Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
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