Ignite Creation Date:
2024-05-06 @ 3:10 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04545164
Status:
COMPLETED
Last Update Posted:
2023-01-26
First Post:
2020-09-01
Brief Title:
Computer Aided Screening for Tuberculosis in Low Resource Environments
Sponsor:
London School of Hygiene and Tropical Medicine
Organization:
London School of Hygiene and Tropical Medicine
Study Overview
Official Title:
Computer Aided Screening for Tuberculosis in Low Resource Environments
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CASTLE
Brief Summary:
People living with HIV PLHIV who require admission to hospital in WHO Africa region have poor outcomes TB is very common in this group but can be difficult to diagnose
The CASTLE trial aims to determine whether systematic screening for tuberculosis using digital chest X-ray with computer-aided diagnosis DCXR-CAD plus urine lipoarabinomannan testing with Fujifilm SILVAMP TB LAM FujiLAM plus usual care can improve admission outcomes for hospitalised PLHIV compared to usual care alone
Our study is a single centre unblinded cluster-randomised by day of admission trial of DCXR-CAD plus FujiLAM plus usual care vs usual care alone for screening for TB in unselected adult PLHIV admitted to a district general hospital in Malawi
The primary outcome is the proportion of people starting TB treatment by the time of death or hospital discharge The secondary outcomes are all-cause mortality at 56 days from enrolment proportion of people starting TB treatment within 24 hours from enrolment and proportion of people with undiagnosed TB In the CASTLE study we collect a single sputum sample for M tb culture from participants and undiagnosed TB specifically refers to a person who did not start TB treatment by the time of death or discharge from hospital and has a M tb cultured from their sputum sample
Alongside the two trial arms a third smaller diagnostic cohort arm 1 in 9 of admission days trial clusters will explore the range of underlying infectious pathology The diagnostic cohort does not contribute to trial outcomes
The CASTLE trial aims to determine whether systematic screening for tuberculosis using digital chest X-ray with computer-aided diagnosis DCXR-CAD plus urine lipoarabinomannan testing with Fujifilm SILVAMP TB LAM FujiLAM plus usual care can improve admission outcomes for hospitalised PLHIV compared to usual care alone
Our study is a single centre unblinded cluster-randomised by day of admission trial of DCXR-CAD plus FujiLAM plus usual care vs usual care alone for screening for TB in unselected adult PLHIV admitted to a district general hospital in Malawi
The primary outcome is the proportion of people starting TB treatment by the time of death or hospital discharge The secondary outcomes are all-cause mortality at 56 days from enrolment proportion of people starting TB treatment within 24 hours from enrolment and proportion of people with undiagnosed TB In the CASTLE study we collect a single sputum sample for M tb culture from participants and undiagnosed TB specifically refers to a person who did not start TB treatment by the time of death or discharge from hospital and has a M tb cultured from their sputum sample
Alongside the two trial arms a third smaller diagnostic cohort arm 1 in 9 of admission days trial clusters will explore the range of underlying infectious pathology The diagnostic cohort does not contribute to trial outcomes
Detailed Description:
CASTLE is funded by Wellcome grant reference 203905Z16Z
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None