Clinical trial NCT04505046: Validation of INSPiRED Innovative Smart Diagnostic Devices for the Detection of Parasites Infections.
Official title: Validation of INSPiRED Innovative Smart Diagnostic Devices for the Detection of Plasmodium Falciparum, Schistosoma Haematobium and Necator Americanus at CERMEL, Gabon.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Testing
Performance
Specificity
Sensitivity
Keywords: Plasmodium
Schistosoma
hookworm
Lead sponsor: Centre de Recherche Médicale de Lambaréné
Sponsor class: OTHER
Collaborators: name: Leiden University Medical Center
First posted: 2020-08-07
Enrollment: 460
Sex: ALL
Minimum age (years): 2
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All study participants, living in Lambaréné areas and its surrounding with parasitic infection

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Infected with malaria
* Infected with Schistosomiasis
* Soil-transmitted helminths

Exclusion Criteria:

-No sample provided

Primary outcomes:
measure: AiDx devise is good as a conventional microscopy
timeFrame: 3 years
measure: Schistoscope
timeFrame: 3 years
measure: Hookworm and other STH devise is good as conventional. microscopic test
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Lambaréné
country: Gabon
facility: Centre de Recherches Medicales de Lambarene
state: Moyen Ogooué
Study officials:
affiliation: Centre de Recherches Médicales de Lambaréné - CERMEL
name: Romuald Mba, MSc
role: STUDY_CHAIR
References: