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

NCT ID: NCT04505046

Last Updated: 2020-08-07

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 460 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-03-20
• Study Completion Date: 2023-12-31

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.

Conditions

Testing; Performance; Specificity; Sensitivity

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

-No sample provided

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Leiden University Medical Center

OTHER

Sponsor Role: collaborator

Centre de Recherche Médicale de Lambaréné

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Romuald Mba, MSc

Role: STUDY_CHAIR

Centre de Recherches Médicales de Lambaréné - CERMEL

Locations

Centre de Recherches Medicales de Lambarene

Lambaréné, Moyen-Ogooué Province, Gabon

Site Status: RECRUITING

Countries

Gabon

Central Contacts

Ayola A ADEGNIKA, PhD; MD

Role: CONTACT

aadegnika@cermel.org

+2466244472

Brice Meulah, MsC

Role: CONTACT

meulahfabrice@gmail.com

+24174567447

Facility Contacts

Ayola A ADEGNIKA

Role: primary

aadegnika@cermel.org

06244472

Brice Meulah

Role: backup

References

Meulah B, Oyibo P, Hoekstra PT, Moure PAN, Maloum MN, Laclong-Lontchi RA, Honkpehedji YJ, Bengtson M, Hokke C, Corstjens PLAM, Agbana T, Diehl JC, Adegnika AA, van Lieshout L. Validation of artificial intelligence-based digital microscopy for automated detection of Schistosoma haematobium eggs in urine in Gabon. PLoS Negl Trop Dis. 2024 Feb 23;18(2):e0011967. doi: 10.1371/journal.pntd.0011967. eCollection 2024 Feb.

Reference Type: DERIVED

PMID: 38394298 (View on PubMed)

Other Identifiers

CEI-005/2020

Identifier Type: -

Identifier Source: org_study_id