Tuberculosis InfectionNew Assay TBNCT04988984
Development of Automated Molecular Diagnostic Platform for Tuberculosis Diagnosis (New Assay TB)
An observational study of Tuberculosis Infection, run by Asan Medical Center at 1 site in South Korea.
Trial 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… Read more about this study
- Who is it for?
- Ages 19 to 100 years
- Conditions the study is for
- Tuberculosis Infection
- How many people
- 400 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Nov 2020to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 100 years
- All sexes
- Adult, Older adult
Study population: 400
Who may be able to join
- Pulmonary TB
- Extrapulmonary TB
Who cannot join
- under 19
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Asan Medical Center, University of Ulsan College of Medicine
Seoul, Songpa, 05505
About this study
Official title: Development of Device Kit for Rapid and Sensitive Diagnostic Method for the Tuberculosis; Using Amine Groups Called HI(Homobifunctional Imidoesters),Negative Charge of the Pathogen and Formed Electrical Bonding to Isolate and Concentrate the Pathogen
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.
Read the detailed description
Usefulness of Pulmonary Tuberculosis Diagnosis A comparison of the new diagnostic method with the Xpert TB/RIF test, which is widely used in clinical practice, that can quickly diagnose pulmonary tuberculosis within 1-2 days. ; Considering the sensitivity of the Xpert TB/RIF test as 70% and the sensitivity of the new diagnostic method as 90%, the number of patients with pulmonary tuberculosis required to confirm that the new diagnostic method is useful is estimated as 90 (study power 90%, alpha error = 0.05). And, if 200 patients with suspected pulmonary tuberculosis are registered, it is possible to verify the clinical usefulness compared to Xpert TB/RIF even in 60 AFB smear negative patients. In addition, for the same reason, if 150 additional patients who underwent bronchoscopy were enrolled, it would be possible to compare the diagnosis rate and utility of sputum and bronchoscopy fluid. Waiting for the tuberculosis bacteria culture test for 6 weeks and using the final culture-positive patient as a gold standard for tuberculosis diagnosis -Usefulness of extrapulmonary tuberculosis diagnosis
Millet tuberculosis is disseminated tuberculosis through blood, and there are numerous millet-like lesions in the lungs, but in fact, the positive rate of AFB smear is low due to paucibacillary TB. It is planned to prove the usefulness of the new test method in 35 people with millet tuberculosis.
- Conditions
- Tuberculosis Infection
- Keywords
- New diagnostic platform,TB
- Medical subject headings
- Latent Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Suspected TB | Patient suspected of TB undergoing diagnostic testing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From date of experiment until the date of first documented progression assessed upto 100 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start17 Nov 2020
- Primary completion17 Nov 2020
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Tuberculosis InfectionStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sei Won Lee, Asan Medical Center
- Investigators
- Seiwon Lee, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04988984
- Sponsor's protocol ID
- 2020-1745
- Acronym
- New Assay TB
- Status last verified
- Jul 2021
- First submitted
- 19 Jul 2021
- Last updated
- 4 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 23101024Diagnostic 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.
PubMed 10764337Lee 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.
PubMed 25861336Wilkinson 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.
PubMed 28884751Boehme 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.
PubMed 20825313Rufai 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.
PubMed 28501491
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of Device Kit for Rapid and Sensitive Diagnostic Method for the Tuberculosis; Using Amine Groups Called HI(Homobifunctional Imidoesters),Negative Charge of the Pathogen and Formed Electrical Bonding to Isolate and Concentrate the Pathogen
- ClinicalTrials.gov ID
- NCT04988984
- Acronym / sponsor ID
- New Assay TB / 2020-1745
- Conditions
- Tuberculosis Infection
- Keywords
- New diagnostic platform,TB
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 17 Nov 2020 (actual)
- Primary completion
- 17 Nov 2020 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 4 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Usefulness of Pulmonary Tuberculosis Diagnosis A comparison of the new diagnostic method with the Xpert TB/RIF test, which is widely used in clinical practice, that can quickly diagnose pulmonary tuberculosis within 1-2 days. ; Considering the sensitivity of the Xpert TB/RIF test as 70% and the sensitivity of the new diagnostic method as 90%, the number of patients with pulmonary tuberculosis required to confirm that the new diagnostic method is useful is estimated as 90 (study power 90%, alpha error = 0.05). And, if 200 patients with suspected pulmonary tuberculosis are registered, it is possible to verify the clinical usefulness compared to Xpert TB/RIF even in 60 AFB smear negative patients. In addition, for the same reason, if 150 additional patients who underwent bronchoscopy were enrolled, it would be possible to compare the diagnosis rate and utility of sputum and bronchoscopy fluid. Waiting for the tuberculosis bacteria culture test for 6 weeks and using the final culture-positive patient as a gold standard for tuberculosis diagnosis -Usefulness of extrapulmonary tuberculosis diagnosis
Millet tuberculosis is disseminated tuberculosis through blood, and there are numerous millet-like lesions in the lungs, but in fact, the positive rate of AFB smear is low due to paucibacillary TB. It is planned to prove the usefulness of the new test method in 35 people with millet tuberculosis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Suspected TB | – | –Patient suspected of TB undergoing diagnostic testing. |
Who may qualify
- Ages
- 19 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 400
Key inclusion criteria (2 listed)
- Pulmonary TB
- Extrapulmonary TB
Key exclusion criteria (1 listed)
- under 19
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity and specificity when using Xpert TB/RIF tests with
Time frame: From date of experiment until the date of first documented progression assessed upto 100 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2021.
- Background: PubMed 23101024Park 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.
- Background: PubMed 10764337Diagnostic 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.
- Background: PubMed 25861336Lee 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.
- Background: PubMed 28884751Wilkinson 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.
- Background: PubMed 20825313Boehme 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.
- Background: PubMed 28501491Rufai 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seiwon Lee principal investigator
Asan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis Infection, run by Asan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity when using Xpert TB/RIF tests with (time frame: From date of experiment until the date of first documented progression assessed upto 100 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04988984, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2021.