Validation of INSPiRED Innovative Smart Diagnostic Devices for the Detection of Parasites Infections. (INSPiRED-WP3)

August 6, 2020 updated by: Centre de Recherche Médicale de Lambaréné

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
460

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Gabon
    • Moyen Ogooué
      • Lambaréné, Moyen Ogooué, Gabon, BP 242
        • Recruiting
        • Centre de Recherches Médicales de Lambaréné
        • Contact:
        • Contact:
          • Brice Meulah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All study participants, living in Lambaréné areas and its surrounding with parasitic infection

Description

Inclusion Criteria:

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

Exclusion Criteria:

-No sample provided

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
3 years
Schistoscope
Time Frame: 3 years
Optical diagnostic devices is specific, sensitive as well as predicting value as microscopic test
3 years
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
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre de Recherche Médicale de Lambaréné

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Leiden University Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Romuald Mba, MSc, Centre de Recherches Médicales de Lambaréné - CERMEL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 20, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 13, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 7, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 7, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 6, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CEI-005/2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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