Multiplex PCR -Microarray-based Assay in the Detection of Mycobacterium

Tuberculosis Clinical Trial

Official title:

Performance of a Multiplex PCR -Microarray-based Assay in the Detection of Mycobacterium Tuberculosis and Non-tuberculous Mycobacterium Species in Smear-positive Pulmonary Clinical Specimens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03794284
• Other study ID #: VereMTB_v2_24_10_2018
• Status: Completed
• Start date: February 28, 2019
• Est. completion date: July 31, 2022

Study information

• Verified date: August 2022
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study will use the VereMTB tool for rapid diagnosis of TB or non-tuberculous mycobacterium (NTM) pulmonary infections in hospitalised patients, with positive results in acid-fast bacilli smears, which are emerging in many regions of the world.

Description:

Delay in diagnosis and treatment of tuberculosis was common in hospitalised patients all around the world, and was associated with poorer outcomes, including respiratory failure and mortality. Rapid and accurate tools for diagnosis of TB is of great importance in initial treatment and for better treatment outcomes. Other than TB, non-tuberculous mycobacterium (NTM) pulmonary infections are emerging in many regions of the world. These bacterium are more common to be found in respiratory specimens than MTB. With similar clinical presentation of NTM pulmonary infections and pulmonary TB, misdiagnosis of NTM pulmonary infections to pulmonary TB would lead to unnecessary intake of anti-TB medications and delay of the initiation of corresponding treatment.

This test aims to detect MTB as well differentiate the NTM species involved in pulmonary infections simultaneously using VereMTB.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: July 31, 2022
• Est. primary completion date: July 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age 18 or older

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:

1. Receiving anti-mycobacterial treatment for more than one week

2. Refusal to consent

Related Conditions & MeSH terms

• Mycobacterium Infections
• Non-Tuberculous Mycobacterial Pneumonia
• Tuberculosis

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Sha Tin

Sponsors (2)

Lead Sponsor	Collaborator
Chinese University of Hong Kong	Prince of Wales Hospital, Shatin, Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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, Gómez-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, Mannsåker T, Marras TK, Maugein J, Milburn HJ, Mlinkó T, Morcillo N, Morimoto K, Papaventsis D, Palenque E, Paez-Peña M, Piersimoni C, Polanová M, Rastogi N, Richter E, Ruiz-Serrano MJ, Silva A, da Silva MP, Simsek H, van Soolingen D, Szabó N, Thomson R, Tórtola 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	diagnostic test correlation	Sensitivity, specificity, positive predictive value, and negative predictive value, will be calculated to determine accuracy of VereMTB, in diagnosing MTB and NTM	6 months from the date of first recruitment