Validation of INSPiRED Innovative Smart Diagnostic Devices for the Detection of Parasites Infections.

Performance Clinical Trial

— INSPiRED-WP3  

Official title:

Validation of INSPiRED Innovative Smart Diagnostic Devices for the Detection of Plasmodium Falciparum, Schistosoma Haematobium and Necator Americanus at CERMEL, Gabon.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04505046
• Other study ID #: CEI-005/2020
• Status: Recruiting
• Start date: March 20, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: August 2020
• Source: Centre de Recherche Médicale de Lambaréné
• Contact: Ayola A ADEGNIKA, PhD; MD
• Phone: +2466244472
• Email: aadegnika[@]cermel.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 460
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 50 Years

Eligibility

Inclusion Criteria:

• Infected with malaria

• Infected with Schistosomiasis

• Soil-transmitted helminths

Exclusion Criteria:

-No sample provided

Related Conditions & MeSH terms

• Hypersensitivity
• Performance
• Respiratory Aspiration
• Sensitivity
• Specificity
• Testing

Locations

Country	Name	City	State
Gabon	Centre de Recherches Medicales de Lambarene	Lambaréné	Moyen Ogooué

Sponsors (2)

Lead Sponsor	Collaborator
Centre de Recherche Médicale de Lambaréné	Leiden University Medical Center

Country where clinical trial is conducted

Gabon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AiDx devise is good as a conventional microscopy	Optical diagnostic devices is specific, sensitive as well as predicting value as microscopic test	3 years
Primary	Schistoscope	Optical diagnostic devices is specific, sensitive as well as predicting value as microscopic test	3 years
Primary	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	3 years