An observational study in Testing, Performance and Specificity, sponsored by Centre de Recherche Médicale de Lambaréné. Status unknown at 1 site in Gabon. Open to participants aged 2 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-07.
Sponsored by Centre de Recherche Médicale de Lambaréné · Observational
Malaria, schistosomiasis and ancylostomiasis are three parasitic diseases which affect hundreds of millions of people and are an important cause of global mortality and morbidity. For the control of these poverty related parasitic diseases, and to complement chemotherapeutic strategies, accurate and accessible diagnostic procedures play a crucial role.
In recent years, innovative smart mobile technologies have been applied for detection and identification of cultured parasite species, which is basically based on sample imaging and parasite morphology identification. Promising advances have been made with this technology and coupled with its small size, low cost and easy to manipulate, makes it suitable for point of care diagnostics in low resource setting.
The aim of the proposed explorative study is to further validate sensitivity and specificity of each of the developed devices, using besides microscopy a range of more advanced reference tests.
Malaria, schistosomiasis and ancylostomiasis are three parasitic diseases which affect hundreds of millions of people and are an important cause of global mortality and morbidity. For the control of these poverty related parasitic diseases, and to complement chemotherapeutic strategies, accurate and accessible diagnostic procedures play a crucial role. Especially in remote and/or low resource settings, appropriate diagnostic tests are often lacking. These tests should not only be sensitive and specific, but also affordable, reliable, and easy to operate. In recent years, innovative smart mobile technologies have been applied for detection and identification of cultured parasite species, which is basically based on sample imaging and parasite morphology identification. Promising advances have been made with this technology and coupled with its small size, low cost and easy to manipulate, makes it suitable for point of care diagnostics in low resource setting. At the Technical University of Delft, a smart optical device prototype has been recently developed for the detection of Plasmodium. This Excelscope has been tested on a small number of malaria cases in Nigeria, showing promising results. In addition, TU Delft has developed a prototype for the detection of Schistosoma haematobium eggs in urine, which is ready for further validation in the field. Still under construction is a smart optical device for the detection of helminth eggs in stool, including eggs of hookworms. For each of these three smart optical devices using respectively blood, urine or stool, a diagnostic performance is aimed which does not significantly deviate in sensitivity and specificity from the diagnostic tests commonly in use in low resource settings, e.g. basic microscopy. At the same time, the optical devices have supplementary logistical advantages, e.g. easiness to use, high throughput and low costs per sample. The aim of the proposed explorative study is to further validate sensitivity and specificity of each of the developed devices, using besides microscopy a range of more advanced reference tests. For this purpose, diagnostic samples (blood, urine, stool) collected from ongoing studies involving malaria, schistosomiasis and STHs. at CERMEL will be used. The outcome of this study will give new insight in the diagnostic performance of the innovative smart optical devices, specifically in comparison to the WHO recommended diagnostic procedures currently used at CERMEL. The study is the core activity of Work Package 3 within the INSPiRED project.
1,055 studies on the registry are indexed under Hypersensitivity; 149 are open to participants now.
This study's planned enrollment of 460 is above the median of 166 across 327 observational studies indexed under Hypersensitivity.
Browse Hypersensitivity studies →Centre de Recherche Médicale de Lambaréné is the lead sponsor of 17 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All study participants, living in Lambaréné areas and its surrounding with parasitic infection
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Exclusion Criteria:
-No sample provided
AiDx devise is good as a conventional microscopy
Optical diagnostic devices is specific, sensitive as well as predicting value as microscopic test
Time frame: 3 years
Schistoscope
Optical diagnostic devices is specific, sensitive as well as predicting value as microscopic test
Time frame: 3 years
Hookworm and other STH devise is good as conventional. microscopic test
Optical diagnostic devices is specific, sensitive as well as predicting value as microscopic test
Time frame: 3 years
Started Mar 2020 (actual). Primary completion is estimated for Dec 2022, 33 months after the start.
Of 101 non-industry observational studies under Hypersensitivity, half reached primary completion within 45 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 203. This study's planned 33 months is below that.
Counting every sponsor, half of 124 studies reached it within 41 months; a quarter within 19 and three quarters within 136.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.
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Centre de Recherche Médicale de Lambaréné