NCT04505046

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
460

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2020

Completed
25 days until next milestone

First Posted

Study publicly available on registry

August 7, 2020

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

August 7, 2020

Status Verified

August 1, 2020

Enrollment Period

2.8 years

First QC Date

July 13, 2020

Last Update Submit

August 6, 2020

Conditions

Keywords

PlasmodiumSchistosomahookworm

Outcome Measures

Primary Outcomes (3)

  • AiDx devise is good as a conventional microscopy

    Optical diagnostic devices is specific, sensitive as well as predicting value as microscopic test

    3 years

  • Schistoscope

    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

    Optical diagnostic devices is specific, sensitive as well as predicting value as microscopic test

    3 years

Eligibility Criteria

Age2 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • No sample provided

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de Recherches Medicales de Lambarene

Lambaréné, Moyen-Ogooué Province, BP 242, Gabon

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

HypersensitivityMalariaSchistosomiasisAncylostomiasis

Condition Hierarchy (Ancestors)

Immune System DiseasesProtozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne DiseasesTrematode InfectionsHelminthiasisHookworm InfectionsStrongylida InfectionsSecernentea InfectionsNematode Infections

Study Officials

  • Romuald Mba, MSc

    Centre de Recherches Médicales de Lambaréné - CERMEL

    STUDY CHAIR

Central Study Contacts

Ayola A ADEGNIKA, PhD; MD

CONTACT

Brice Meulah, MsC

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2020

First Posted

August 7, 2020

Study Start

March 20, 2020

Primary Completion

December 31, 2022

Study Completion

December 31, 2023

Last Updated

August 7, 2020

Record last verified: 2020-08

Locations