NCT05899400

Brief Summary

A Study to Validate and Improve an Automated Image Analysis Algorithm to Detect Tuberculosis in Sputum Smear Slides

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

September 15, 2019

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 12, 2023

Completed
Last Updated

June 12, 2023

Status Verified

June 1, 2023

Enrollment Period

3.1 years

First QC Date

May 31, 2023

Last Update Submit

June 8, 2023

Conditions

Tuberculosis, Pulmonary

Outcome Measures

Primary Outcomes (1)

  • Determined sensitivity and specificity of the iON device by comparing MTB slide results to their associated bacterial culture results from the same specimen(s).

    Sensitivity, specificity, and average analysis time were determined. An image database of \>40,000 images was also created for internal use.

    Study completed over the grant period 2019 - 2022

Study Arms (1)

Study Group

400 Male and Female Ugandan Africans

Diagnostic Test: Diascopic iON Image Analysis System

Interventions

Diascopic iON Image Analysis SystemDIAGNOSTIC_TEST

A scanning digital optical train that images sputum slides for automated analysis by a tuberculosis detecting algorithm

Study Group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

400 Male and Female Ugandan Africans

You may qualify if:

  • Samples sourced from Makerere University's Joint Clinical Research Clinic (JCRC) and Laboratory

You may not qualify if:

  • No samples from outside Makerere's Domain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Makerere University

Kampala, Uganda

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Mycobacterium Sputum Slides

MeSH Terms

Conditions

Tuberculosis, Pulmonary

Condition Hierarchy (Ancestors)

TuberculosisMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsRespiratory Tract InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Moses Joloba, MD, PhD

    Makerere University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2023

First Posted

June 12, 2023

Study Start

September 15, 2019

Primary Completion

October 31, 2022

Study Completion

December 31, 2022

Last Updated

June 12, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

UG(1)