TestingINSPiRED-WP3NCT04505046
Validation of INSPiRED Innovative Smart Diagnostic Devices for the Detection of Parasites Infections.
An observational study of Testing and Performance, run by Centre de Recherche Médicale de Lambaréné at 1 site in Gabon.
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. Read more about this study
- Who is it for?
- Ages 2 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Testing, Performance, Specificity
- How many people
- 460 participants
- Where
- 1 siteGabon
- Study dates
- 20 Mar 2020to 31 Dec 2023
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: All study participants, living in Lambaréné areas and its surrounding with parasitic infection
Who may be able to join
- Infected with malaria
- Infected with Schistosomiasis
- Soil-transmitted helminths
Who cannot join
- -No sample provided
Trial locations and contacts
1 site in 1 country.
Gabon1 site, 1 recruiting
- Recruiting
Centre de Recherches Medicales de Lambarene
Lambaréné, Moyen-Ogooué Province, BP 242
Ayola A ADEGNIKA, 06244472, aadegnika@cermel.org
Brice Meulah
About this study
Official title: Validation of INSPiRED Innovative Smart Diagnostic Devices for the Detection of Plasmodium Falciparum, Schistosoma Haematobium and Necator Americanus at CERMEL, Gabon.
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.
Read the 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
- Keywords
- Plasmodium, Schistosoma, hookworm
- Medical subject headings
- Hypersensitivity, Malaria, Schistosomiasis, Ancylostomiasis
What is being measured
The primary outcome is the main question the study is designed to answer.
AiDx devise is good as a conventional microscopy
Optical diagnostic devices is specific, sensitive as well as predicting value as microscopic test
Measured: 3 years
Schistoscope
Optical diagnostic devices is specific, sensitive as well as predicting value as microscopic test
Measured: 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
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start20 Mar 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TestingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 460 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Centre de Recherche Médicale de Lambaréné
- Sponsor type
- University, hospital or other
- Collaborators
- Leiden University Medical Center
- Responsible party
- Sponsor
- Investigators
- Romuald Mba, MSc, Study chair, Centre de Recherches Médicales de Lambaréné - CERMEL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04505046
- Sponsor's protocol ID
- CEI-005/2020
- Acronym
- INSPiRED-WP3
- Status last verified
- Aug 2020
- First submitted
- 13 Jul 2020
- Last updated
- 7 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38394298
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of INSPiRED Innovative Smart Diagnostic Devices for the Detection of Plasmodium Falciparum, Schistosoma Haematobium and Necator Americanus at CERMEL, Gabon.
- ClinicalTrials.gov ID
- NCT04505046
- Acronym / sponsor ID
- INSPiRED-WP3 / CEI-005/2020
- Conditions
- Testing, Performance, Specificity, Sensitivity
- Keywords
- Plasmodium, Schistosoma, hookworm
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 460 participants (estimated)
- Lead sponsor
- Centre de Recherche Médicale de LambarénéUniversity, hospital or other
- Collaborators
- Leiden University Medical Center
- Study start
- 20 Mar 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 7 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 2 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- All study participants, living in Lambaréné areas and its surrounding with parasitic infection
Key inclusion criteria (3 listed)
- Infected with malaria
- Infected with Schistosomiasis
- Soil-transmitted helminths
Key exclusion criteria (1 listed)
- -No sample provided
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
AiDx devise is good as a conventional microscopy
Time frame: 3 years
Optical diagnostic devices is specific, sensitive as well as predicting value as microscopic test
Schistoscope
Time frame: 3 years
Optical diagnostic devices is specific, sensitive as well as predicting value as microscopic test
Hookworm and other STH devise is good as conventional. microscopic test
Time frame: 3 years
Optical diagnostic devices is specific, sensitive as well as predicting value as microscopic test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2020.
- Derived from this study: PubMed 38394298Meulah 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Romuald Mba, MSc study chair
Centre de Recherches Médicales de Lambaréné - CERMEL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Testing and Performance, run by Centre de Recherche Médicale de Lambaréné at 1 site in Gabon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Gabon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ayola A ADEGNIKA, PhD; MD (+2466244472, aadegnika@cermel.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AiDx devise is good as a conventional microscopy (time frame: 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04505046, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2020.