Multiplex PCR -Microarray-based Assay in the Detection of Mycobacterium
NCT ID: NCT03794284
Last Updated: 2022-08-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
46 participants
OBSERVATIONAL
2019-02-28
2022-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Establishing a Diagnostic Test for Non-tuberculous Mycobacteria Lung Infection Using Non-tuberculous Mycobacteria Antigen Stimulation Test: From Immune Base, Standardized Setup to Validation
NCT01676142
Application of GeneXpert on Bronchoscopic Samples for Patients Suspicious of TB
NCT02838641
Quantitative Measurement of Plasma and Urine MTB Cell-free DNA Level
NCT07170735
Plasma MTB cfDNA Before Bronchoscopy
NCT07230457
Co-Infection of NTM in Patients With Smear Positive Pulmonary TB
NCT00567151
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
This test aims to detect MTB as well differentiate the NTM species involved in pulmonary infections simultaneously using VereMTB.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_ONLY
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
VereMTB
At least 2 mL of patient's expectorated or induced sputum would be collected for VereMTB assay and their clinical data would be retrieved for analysis use.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. One or more symptoms compatible with mycobacterial pulmonary infections, including fever, cough, sputum production,hemoptysis dyspnea, chest pain and weight loss
3. One or more sputum samples with positive AFB smear
Exclusion Criteria
2. Refusal to consent
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Prince of Wales Hospital, Shatin, Hong Kong
OTHER
Chinese University of Hong Kong
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Grace Lui
Assistant Professor and Head, Division of Infectious Diseases
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Chung Yan Grace Lui
Role: PRINCIPAL_INVESTIGATOR
Chinese University of Hong Kong
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Prince of Wales Hospital
Shatin, , Hong Kong
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
GBD Tuberculosis Collaborators. The global burden of tuberculosis: results from the Global Burden of Disease Study 2015. Lancet Infect Dis. 2018 Mar;18(3):261-284. doi: 10.1016/S1473-3099(17)30703-X. Epub 2017 Dec 7.
Lui G, Wong RY, Li F, Lee MK, Lai RW, Li TC, Kam JK, Lee N. High mortality in adults hospitalized for active tuberculosis in a low HIV prevalence setting. PLoS One. 2014 Mar 18;9(3):e92077. doi: 10.1371/journal.pone.0092077. eCollection 2014.
Bhurayanontachai R, Maneenil K. Factors influencing development and mortality of acute respiratory failure in hospitalized patient with active pulmonary tuberculosis: a 10-year retrospective review. J Thorac Dis. 2016 Jul;8(7):1721-30. doi: 10.21037/jtd.2016.06.22.
Namkoong H, Kurashima A, Morimoto K, Hoshino Y, Hasegawa N, Ato M, Mitarai S. Epidemiology of Pulmonary Nontuberculous Mycobacterial Disease, Japan. Emerg Infect Dis. 2016 Jun;22(6):1116-7. doi: 10.3201/eid2206.151086. No abstract available.
Kim HS, Lee Y, Lee S, Kim YA, Sun YK. Recent trends in clinically significant nontuberculous Mycobacteria isolates at a Korean general hospital. Ann Lab Med. 2014 Jan;34(1):56-9. doi: 10.3343/alm.2014.34.1.56. Epub 2013 Dec 6.
Chien JY, Lai CC, Sheng WH, Yu CJ, Hsueh PR. Pulmonary infection and colonization with nontuberculous mycobacteria, Taiwan, 2000-2012. Emerg Infect Dis. 2014 Aug;20(8):1382-5. doi: 10.3201/eid2008.131673.
Lan R, Yang C, Lan L, Ou J, Qiao K, Liu F, Gao Q. Mycobacterium tuberculosis and non-tuberculous mycobacteria isolates from HIV-infected patients in Guangxi, China. Int J Tuberc Lung Dis. 2011 Dec;15(12):1669-75. doi: 10.5588/ijtld.11.0036.
McCarthy KD, Cain KP, Winthrop KL, Udomsantisuk N, Lan NT, Sar B, Kimerling ME, Kanara N, Lynen L, Monkongdee P, Tasaneeyapan T, Varma JK. Nontuberculous mycobacterial disease in patients with HIV in Southeast Asia. Am J Respir Crit Care Med. 2012 May 1;185(9):981-8. doi: 10.1164/rccm.201107-1327OC. Epub 2012 Feb 16.
Cabibbe AM, Miotto P, Moure R, Alcaide F, Feuerriegel S, Pozzi G, Nikolayevskyy V, Drobniewski F, Niemann S, Reither K, Cirillo DM; TM-REST Consortium; TB-CHILD Consortium. Lab-on-Chip-Based Platform for Fast Molecular Diagnosis of Multidrug-Resistant Tuberculosis. J Clin Microbiol. 2015 Dec;53(12):3876-80. doi: 10.1128/JCM.01824-15. Epub 2015 Aug 5.
Lazzeri E, Santoro F, Oggioni MR, Iannelli F, Pozzi G. Novel primer-probe sets for detection and identification of mycobacteria by PCR-microarray assay. J Clin Microbiol. 2012 Nov;50(11):3777-9. doi: 10.1128/JCM.02300-12. Epub 2012 Sep 12.
Hoefsloot W, van Ingen J, Andrejak C, Angeby K, Bauriaud R, Bemer P, Beylis N, Boeree MJ, Cacho J, Chihota V, Chimara E, Churchyard G, Cias R, Daza R, Daley CL, Dekhuijzen PN, Domingo D, Drobniewski F, Esteban J, Fauville-Dufaux M, Folkvardsen DB, Gibbons N, Gomez-Mampaso E, Gonzalez R, Hoffmann H, Hsueh PR, Indra A, Jagielski T, Jamieson F, Jankovic M, Jong E, Keane J, Koh WJ, Lange B, Leao S, Macedo R, Mannsaker T, Marras TK, Maugein J, Milburn HJ, Mlinko T, Morcillo N, Morimoto K, Papaventsis D, Palenque E, Paez-Pena M, Piersimoni C, Polanova M, Rastogi N, Richter E, Ruiz-Serrano MJ, Silva A, da Silva MP, Simsek H, van Soolingen D, Szabo N, Thomson R, Tortola Fernandez T, Tortoli E, Totten SE, Tyrrell G, Vasankari T, Villar M, Walkiewicz R, Winthrop KL, Wagner D; Nontuberculous Mycobacteria Network European Trials Group. The geographic diversity of nontuberculous mycobacteria isolated from pulmonary samples: an NTM-NET collaborative study. Eur Respir J. 2013 Dec;42(6):1604-13. doi: 10.1183/09031936.00149212. Epub 2013 Apr 18.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
VereMTB_v2_24_10_2018
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.