Development of Automated Molecular Diagnostic Platform for Tuberculosis Diagnosis (New Assay TB)

NCT04988984 | Unknown

• 1 other identifier: 2020-1745
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

It is intended for patients who have been admitted to the outpatient or emergency room or are hospitalized For patients who diagnose pulmonary tuberculosis or extrapulmonary tuberculosis using Xpert TB/RIF, additionally, diagnose pulmonary tuberculosis or extrapulmonary tuberculosis using a new diagnostic method, and check the test results. Check whether the tuberculosis bacteria were actually cultured in the sample in the future, and compare the sensitivity and specificity in each test. Validation in animal model In an animal model (rat) with chronic obstructive pulmonary disease that shows similar characteristics to tuberculosis destructive lung, It will be investigated whether the HI method can be validated by separating and concentrating microbiome for various pathogens including Mycobacterium tuberculosis using HI method. Confirm.

Conditions

Tuberculosis Infection

Keywords

New diagnostic platform,TB

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity when using Xpert TB/RIF tests with

  Comparison of sensitivity and specificity of existing Xpert TB/RIF tests and new diagnostic methods using Homobifunctional Imidoesters (HI) compounds in diagnosing suspected cases of pulmonary tuberculosis and pulmonary tuberculosis And the sensitivity and specificity of these two test results are evaluated by waiting for the tuberculosis bacillus culture test for 6 weeks and using the final culture-positive patient as a gold standard for tuberculosis diagnosis.

  From date of experiment until the date of first documented progression assessed upto 100 months

Study Arms (1)

Suspected TB

Patient suspected of TB undergoing diagnostic testing.

Eligibility Criteria

• Age: 19 Years - 100 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

400

You may qualify if:

• Pulmonary TB
• Extrapulmonary TB

You may not qualify if:

• under 19

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (1)

Asan Medical Center, University of Ulsan College of Medicine

Seoul, Songpa, 05505, South Korea

Location

Related Publications (6)

• Park YS, Hong SJ, Boo YK, Hwang ES, Kim HJ, Cho SH, Na KI, Cho EH, Shin SS. The national status of tuberculosis using nationwide medical records survey of patients with tuberculosis in Korea. Tuberc Respir Dis (Seoul). 2012 Jul;73(1):48-55. doi: 10.4046/trd.2012.73.1.48. Epub 2012 Jul 31.

  PMID: 23101024 BACKGROUND

• Diagnostic Standards and Classification of Tuberculosis in Adults and Children. This official statement of the American Thoracic Society and the Centers for Disease Control and Prevention was adopted by the ATS Board of Directors, July 1999. This statement was endorsed by the Council of the Infectious Disease Society of America, September 1999. Am J Respir Crit Care Med. 2000 Apr;161(4 Pt 1):1376-95. doi: 10.1164/ajrccm.161.4.16141. No abstract available.

  PMID: 10764337 BACKGROUND

• Lee JY. Diagnosis and treatment of extrapulmonary tuberculosis. Tuberc Respir Dis (Seoul). 2015 Apr;78(2):47-55. doi: 10.4046/trd.2015.78.2.47. Epub 2015 Apr 2.

  PMID: 25861336 BACKGROUND

• Wilkinson RJ, Rohlwink U, Misra UK, van Crevel R, Mai NTH, Dooley KE, Caws M, Figaji A, Savic R, Solomons R, Thwaites GE; Tuberculous Meningitis International Research Consortium. Tuberculous meningitis. Nat Rev Neurol. 2017 Oct;13(10):581-598. doi: 10.1038/nrneurol.2017.120. Epub 2017 Sep 8.

  PMID: 28884751 BACKGROUND

• Boehme CC, Nabeta P, Hillemann D, Nicol MP, Shenai S, Krapp F, Allen J, Tahirli R, Blakemore R, Rustomjee R, Milovic A, Jones M, O'Brien SM, Persing DH, Ruesch-Gerdes S, Gotuzzo E, Rodrigues C, Alland D, Perkins MD. Rapid molecular detection of tuberculosis and rifampin resistance. N Engl J Med. 2010 Sep 9;363(11):1005-15. doi: 10.1056/NEJMoa0907847. Epub 2010 Sep 1.

  PMID: 20825313 BACKGROUND

• Rufai SB, Singh A, Singh J, Kumar P, Sankar MM, Singh S; TB Research Team. Diagnostic usefulness of Xpert MTB/RIF assay for detection of tuberculous meningitis using cerebrospinal fluid. J Infect. 2017 Aug;75(2):125-131. doi: 10.1016/j.jinf.2017.04.010. Epub 2017 May 10.

  PMID: 28501491 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Oral swab,BAL, Pleural fluid,Sputum of agreed Subject

MeSH Terms

Conditions

Latent Tuberculosis

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Latent Infection

Study Officials

• Seiwon Lee

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 19, 2021
• First Posted: August 4, 2021
• Study Start: November 17, 2020
• Primary Completion: November 17, 2020
• Study Completion: December 31, 2023
• Last Updated: August 4, 2021

Record last verified: 2021-07

Locations

KR (1)