Ignite Creation Date:
2024-05-06 @ 3:32 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04666311
Status:
COMPLETED
Last Update Posted:
2022-09-09
First Post:
2020-12-07
Brief Title:
Diagnostic Accuracy of CAD4TB and C-reactive Protein Assay as Triage Tests for Pulmonary Tuberculosis
Sponsor:
Klaus Reither
Organization:
Swiss Tropical Public Health Institute
Study Overview
Official Title:
Prospective Multicentre Evaluation of the Accuracy of CAD4TB and C-reactive Protein Assay as Triage Tests for the Diagnosis of Pulmonary Tuberculosis in Presumptive Adult TB Patients TB TRIAGE Accuracy
Status:
COMPLETED
Status Verified Date:
2022-09
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:
TB TRIAGE
Brief Summary:
In the TB TRIAGE ACCURACY study the accuracy of the following products will be determined
CAD4TB Delft Imaging System NL a digital chest x-ray analysis software
Afinion CRP assay Alere Afinion USA which detects a cytokine induced acute phase protein
CAD4TB and the C-reactive protein assay are two tests with great potential of becoming a triage test for the diagnosis of tuberculosis TB These potential triage tests for TB are intended to serve as rule-out tests with a high sensitivity and negative predictive value
Before impact and cost-effectiveness of new TB triage tests for intensified active case finding can be determined the diagnostic test accuracy needs to be assessed in comparison to confirmatory reference tests This accuracy study will define cut-off values for CAD4TB as well as for the Afinion CRP assay to be used in a future cluster-randomised trial on impact and cost-effectiveness of TB triage strategies for intensified active case finding in Lesotho and KwaZulu-Natal South Africa
A sub-study detailed in a separate study protocol hereafter called AHD-FEASIBILITY explores the feasibility of implementing a series of point-of-care tests including the new VISITECT CD4 Advanced Disease Test Omega Diagnostics UK as part of the WHO-recommended advanced HIV Disease care package in the context of community-based HIVTB campaigns
Due to the coinciding pandemics and the overlapping symptoms of TB and COVID-19 it is critical to test for SARS-Cov-2 infections in the study population In addition this study will contribute to the evaluation of a novel SARS-Cov-2 antigen rapid diagnostic test from the diagnostic pipeline of FIND and CAD4COVID a digital chest x-ray analysis software Delft Imaging System NL in combination with differential white blood cell count
CAD4TB Delft Imaging System NL a digital chest x-ray analysis software
Afinion CRP assay Alere Afinion USA which detects a cytokine induced acute phase protein
CAD4TB and the C-reactive protein assay are two tests with great potential of becoming a triage test for the diagnosis of tuberculosis TB These potential triage tests for TB are intended to serve as rule-out tests with a high sensitivity and negative predictive value
Before impact and cost-effectiveness of new TB triage tests for intensified active case finding can be determined the diagnostic test accuracy needs to be assessed in comparison to confirmatory reference tests This accuracy study will define cut-off values for CAD4TB as well as for the Afinion CRP assay to be used in a future cluster-randomised trial on impact and cost-effectiveness of TB triage strategies for intensified active case finding in Lesotho and KwaZulu-Natal South Africa
A sub-study detailed in a separate study protocol hereafter called AHD-FEASIBILITY explores the feasibility of implementing a series of point-of-care tests including the new VISITECT CD4 Advanced Disease Test Omega Diagnostics UK as part of the WHO-recommended advanced HIV Disease care package in the context of community-based HIVTB campaigns
Due to the coinciding pandemics and the overlapping symptoms of TB and COVID-19 it is critical to test for SARS-Cov-2 infections in the study population In addition this study will contribute to the evaluation of a novel SARS-Cov-2 antigen rapid diagnostic test from the diagnostic pipeline of FIND and CAD4COVID a digital chest x-ray analysis software Delft Imaging System NL in combination with differential white blood cell count
Detailed Description:
This is a prospective partially blinded two-centre cross-sectional study in which the diagnostic test accuracy of CAD4TB and an Afinion CRP assay test for TB will be assessed at facility level by evaluating a sample of 1400 adults age 18years with one or more TB symptoms WHO recommended four-symptom screening cough weight loss night sweats fever of any duration
Presumptive TB patients will be recruited i at the outpatient departments of the Butha-Buthe District Hospital Butha-Buthe Lesotho and the Caluza Clinic Pietermaritzburg KwaZulu-Natal South Africa and ii during community-based health campaigns by SolidarMed in Lesotho and HSRC in South Africa Participants will be enrolled after giving written informed consent
Study procedures comprise the following detailed in the schedule of events collection of contact anthropometric demographic and clinical data HIV testing and counselling per national guidelines collection of capillary blood for HIV testing Afinion CRP assay differential white blood cell count VISITECT CD4 Advanced Disease Test if HIV-positive CrAg Lateral Flow Assay if HIV positive and CD4 count 200 cellsĪ¼l as per VISITECT CD4 Advanced Disease Test and no history of cryptococcal meningitis treatment collection of urine if HIV positive for Alere Determine TB LAM Ag test chest radiography for CAD4TB and CAD4COVID analysis and remote expert reading nasopharyngeal swabs for SARS-Cov-2 real-time PCR and SARS-Cov-2 antigen test collection of two spot sputa samples S1S2 for Xpert MTBRIF Xpert MTBRIF Ultra S1 and for mycobacterial culture MGIT S2 At week 12 2weeks we will contact each participant by phone and collect data on their vital status and any TB treatment since enrolment For individuals on TB treatment further information eg on reasons for empirical treatment will be collected at the health facility the participant started TB treatment
Presumptive TB patients will be recruited i at the outpatient departments of the Butha-Buthe District Hospital Butha-Buthe Lesotho and the Caluza Clinic Pietermaritzburg KwaZulu-Natal South Africa and ii during community-based health campaigns by SolidarMed in Lesotho and HSRC in South Africa Participants will be enrolled after giving written informed consent
Study procedures comprise the following detailed in the schedule of events collection of contact anthropometric demographic and clinical data HIV testing and counselling per national guidelines collection of capillary blood for HIV testing Afinion CRP assay differential white blood cell count VISITECT CD4 Advanced Disease Test if HIV-positive CrAg Lateral Flow Assay if HIV positive and CD4 count 200 cellsĪ¼l as per VISITECT CD4 Advanced Disease Test and no history of cryptococcal meningitis treatment collection of urine if HIV positive for Alere Determine TB LAM Ag test chest radiography for CAD4TB and CAD4COVID analysis and remote expert reading nasopharyngeal swabs for SARS-Cov-2 real-time PCR and SARS-Cov-2 antigen test collection of two spot sputa samples S1S2 for Xpert MTBRIF Xpert MTBRIF Ultra S1 and for mycobacterial culture MGIT S2 At week 12 2weeks we will contact each participant by phone and collect data on their vital status and any TB treatment since enrolment For individuals on TB treatment further information eg on reasons for empirical treatment will be collected at the health facility the participant started TB treatment
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?:
False
Is an FDA AA801 Violation?:
None