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D014397: Tuberculosis, Pulmonary

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Correlated Drug Terms (2)


Name (Synonyms) Correlation
drug547 CAD4COVID+WBC and COVID-19 RDT for SARS-CoV-2 infection Wiki 1.00
drug145 Accuracy of CAD4TB and Afinion CRP assay for pulmonary TB Wiki 1.00

Correlated MeSH Terms (1)


Name (Synonyms) Correlation
D014376 Tuberculosis NIH 0.50

Correlated HPO Terms (0)


Name (Synonyms) Correlation

Clinical Trials

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There is one clinical trial.


1 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)

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 HIV/TB 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.

NCT04666311
Conditions
  1. Pulmonary Tuberculosis
  2. Tuberculosis Diagnosis
  3. Covid-19
  4. HIV
Interventions
  1. Diagnostic Test: Accuracy of CAD4TB and Afinion CRP assay for pulmonary TB
  2. Diagnostic Test: CAD4COVID+WBC and COVID-19 RDT for SARS-CoV-2 infection
MeSH:Tuberculosis Tuberculosis, Pulmonary

Primary Outcomes

Description: Receiver operating characteristic analysis (ROC) of CAD4TB against a composite microbiological reference standard (mycobacterial culture [MGIT] or Xpert MTB/RIF) to define an acceptable diagnostic cut-off value.

Measure: Determine CAD4TB cut-off value

Time: 15 months after first patient visit

Description: Receiver operating characteristic analysis (ROC) of Afinion CRP assay against a composite microbiological reference standard (mycobacterial culture [MGIT] or Xpert MTB/RIF) to define an acceptable diagnostic cut-off value.

Measure: Determine Afinion CRP assay cut-off value

Time: 15 months after first patient visit

Secondary Outcomes

Description: Receiver operating characteristic analysis (ROC) of CAD4TB against a single microbiological reference standard (mycobacterial culture [MGIT] alone, Xpert MTB/RIF alone, Xpert MTB/RIF Ultra alone), against a composite reference standard and against a radiological reference standard

Measure: Evaluate CAD4TB ROC against reference standard

Time: 15 months after first patient visit

Description: Receiver operating characteristic analysis (ROC) of Afinion CRP assay against a single microbiological reference standard (mycobacterial culture [MGIT] alone, Xpert MTB/RIF alone, Xpert MTB/RIF Ultra alone) and against a composite reference standard

Measure: Evaluate Afinion CRP assay ROC against reference standard

Time: 15 months after first patient visit

Description: Receiver operating characteristic analysis (ROC) of CAD4COVID combined with differential white blood cell count and point estimates of sensitivity and specificity the novel SARS-Cov-2 antigen rapid diagnostic test, both against a single microbiological reference standard (SARS-Cov-2 real-time PCR)

Measure: Evaluate CAD4COVID and COVID-19 RDT ROC against reference standard

Time: 15 months after first patient visit

HPO Nodes


HPO

Alphabetical listing of all HPO terms. Navigate: Correlations   Clinical Trials


HPO Nodes


Reports

Data processed on January 01, 2021.

An HTML report was created for each of the unique drugs, MeSH, and HPO terms associated with COVID-19 clinical trials. Each report contains a list of either the drug, the MeSH terms, or the HPO terms. All of the terms in a category are displayed on the left-hand side of the report to enable easy navigation, and the reports contain a list of correlated drugs, MeSH, and HPO terms. Further, all reports contain the details of the clinical trials in which the term is referenced. Every clinical trial report shows the mapped HPO and MeSH terms, which are also hyperlinked. Related HPO terms, with their associated genes, protein mutations, and SNPs are also referenced in the report.

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