Xpert MTB/RIF Test in the Diagnosis of Pulmonary Tuberculosis
NCT ID: NCT04433195
Last Updated: 2022-05-12
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
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UNKNOWN
NA
6900 participants
INTERVENTIONAL
2020-06-15
2022-12-31
Brief Summary
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Detailed Description
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Group A (Immediate NAA by clinician): NAA as the initial diagnostic test for pulmonary TB requested by clinicians.
Group B (Immediate NAA as intervention): NAA as the initial diagnostic test for pulmonary TB not requested by clinicians, but is performed as intervention in this study (intervention group).
Group C (No immediate NAA): NAA as the initial diagnostic test for pulmonary TB not requested by clinicians, and is not performed as the initial diagnostic test in this study (control group). NAA may be ordered at a later point in time by clinicians as an add-on test after sputum smear microscopy.
The investigators will assess pulmonary TB cases detected in all groups regarding
1. The interval between sputum examinations and initiation of ant-TB treatment.
2. The proportion of culture confirmed pulmonary TB among all pulmonary TB cases notified.
3. The proportion of TB patients who are advised to stop anti-TB treatment before completion of a treatment course.
4. Outcome of tuberculosis treatment, including patients who die before anti-TB treatment.
Among patients with NAA as the initial diagnostic test (Group A and Group B), the investigators will investigate
1. Performance (sensitivity, specificity and predictive values) of NAA in the diagnosis of culture positive pulmonary TB.
2. The incremental yield of the second and third smear in patients who have both NAA test and smear microscopy as the initial diagnostic test, aiming to determine the contribution of the second and third smear in the diagnosis of pulmonary TB.
3. The proportion of NAA positive cases who were culture negative.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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Immediate NAA by clinician
Nucleic acid amplification test requested by clinicians as the initial diagnostic test for the diagnosis of pulmonary TB
Xpert MTB/RIF test
Xpert MTB/RIF performed as the initial diagnostic test for the diagnosis of pulmonary TB
Immediate NAA as intervention
Nucleic acid amplification test not requested by clinicians as the initial diagnostic test for the diagnosis of pulmonary TB, but Xpert MTB/RIF is performed as intervention in this study (intervention group)
Xpert MTB/RIF test
Xpert MTB/RIF performed as the initial diagnostic test for the diagnosis of pulmonary TB
No immediate NAA
Nucleic acid amplification test not requested by clinicians as the initial diagnostic test for the diagnosis of pulmonary TB, and Xpert MTB/RIF is not performed as the initial diagnostic test in this study (control group). Nucleic acid amplification test may be ordered at a later point in time by clinicians as an add-on test after sputum smear microscopy
No interventions assigned to this group
Interventions
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Xpert MTB/RIF test
Xpert MTB/RIF performed as the initial diagnostic test for the diagnosis of pulmonary TB
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
20 Years
ALL
No
Sponsors
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Buddhist Tzu Chi General Hospital
OTHER
Chest Hospital, Ministry of Health and Welfare, Taiwan
OTHER_GOV
Chang-Hua Hospital
OTHER_GOV
Taichung Veterans General Hospital
OTHER
Taipei Medical University WanFang Hospital
OTHER
Responsible Party
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Principal Investigators
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Chen-Yuan Chiang, MD,DrPhilos
Role: PRINCIPAL_INVESTIGATOR
Wan Fang Hospital, Taipei Medical University, Taiwan
Locations
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Chang-Hua Hospital
Chang-hua, , Taiwan
Buddhist Tzu Chi General Hospital
Hualien City, , Taiwan
Taichung Veterans General Hospital
Taichung, , Taiwan
Chest Hospital, Ministry of Health and Welfare
Tainan City, , Taiwan
Wan Fang Hospital, Taipei Medical University
Taipei, , Taiwan
Countries
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References
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Chiang CY, Enarson DA, Bai KJ, Suo J, Wu YC, Lin TP, Luh KT. Factors associated with a clinician's decision to stop anti-tuberculosis treatment before completion. Int J Tuberc Lung Dis. 2008 Apr;12(4):441-6.
Chiang CY, Chang CT, Chang RE, Li CT, Huang RM. Patient and health system delays in the diagnosis and treatment of tuberculosis in Southern Taiwan. Int J Tuberc Lung Dis. 2005 Sep;9(9):1006-12.
Chen CC, Chiang CY, Pan SC, Wang JY, Lin HH. Health system delay among patients with tuberculosis in Taiwan: 2003-2010. BMC Infect Dis. 2015 Nov 2;15:491. doi: 10.1186/s12879-015-1228-x.
Pan SC, Chen YC, Wang JY, Sheng WH, Lin HH, Fang CT, Chang SC. Tuberculosis in Healthcare Workers: A Matched Cohort Study in Taiwan. PLoS One. 2015 Dec 17;10(12):e0145047. doi: 10.1371/journal.pone.0145047. eCollection 2015.
Boehme CC, Nicol MP, Nabeta P, Michael JS, Gotuzzo E, Tahirli R, Gler MT, Blakemore R, Worodria W, Gray C, Huang L, Caceres T, Mehdiyev R, Raymond L, Whitelaw A, Sagadevan K, Alexander H, Albert H, Cobelens F, Cox H, Alland D, Perkins MD. Feasibility, diagnostic accuracy, and effectiveness of decentralised use of the Xpert MTB/RIF test for diagnosis of tuberculosis and multidrug resistance: a multicentre implementation study. Lancet. 2011 Apr 30;377(9776):1495-505. doi: 10.1016/S0140-6736(11)60438-8. Epub 2011 Apr 18.
Hermans S, Caldwell J, Kaplan R, Cobelens F, Wood R. The impact of the roll-out of rapid molecular diagnostic testing for tuberculosis on empirical treatment in Cape Town, South Africa. Bull World Health Organ. 2017 Aug 1;95(8):554-563. doi: 10.2471/BLT.16.185314. Epub 2017 Apr 28.
Cox H, Dickson-Hall L, Ndjeka N, Van't Hoog A, Grant A, Cobelens F, Stevens W, Nicol M. Delays and loss to follow-up before treatment of drug-resistant tuberculosis following implementation of Xpert MTB/RIF in South Africa: A retrospective cohort study. PLoS Med. 2017 Feb 21;14(2):e1002238. doi: 10.1371/journal.pmed.1002238. eCollection 2017 Feb.
Cox HS, Mbhele S, Mohess N, Whitelaw A, Muller O, Zemanay W, Little F, Azevedo V, Simpson J, Boehme CC, Nicol MP. Impact of Xpert MTB/RIF for TB diagnosis in a primary care clinic with high TB and HIV prevalence in South Africa: a pragmatic randomised trial. PLoS Med. 2014 Nov 25;11(11):e1001760. doi: 10.1371/journal.pmed.1001760. eCollection 2014 Nov.
Naidoo P, Dunbar R, Lombard C, du Toit E, Caldwell J, Detjen A, Squire SB, Enarson DA, Beyers N. Comparing Tuberculosis Diagnostic Yield in Smear/Culture and Xpert(R) MTB/RIF-Based Algorithms Using a Non-Randomised Stepped-Wedge Design. PLoS One. 2016 Mar 1;11(3):e0150487. doi: 10.1371/journal.pone.0150487. eCollection 2016.
Calligaro GL, Zijenah LS, Peter JG, Theron G, Buser V, McNerney R, Bara W, Bandason T, Govender U, Tomasicchio M, Smith L, Mayosi BM, Dheda K. Effect of new tuberculosis diagnostic technologies on community-based intensified case finding: a multicentre randomised controlled trial. Lancet Infect Dis. 2017 Apr;17(4):441-450. doi: 10.1016/S1473-3099(16)30384-X. Epub 2017 Jan 5.
Mbonze NB, Tabala M, Wenzi LK, Bakoko B, Brouwer M, Creswell J, Van Rie A, Behets F, Yotebieng M. Xpert((R)) MTB/RIF for smear-negative presumptive TB: impact on case notification in DR Congo. Int J Tuberc Lung Dis. 2016 Feb;20(2):240-6. doi: 10.5588/ijtld.15.0177.
Automated Real-Time Nucleic Acid Amplification Technology for Rapid and Simultaneous Detection of Tuberculosis and Rifampicin Resistance: Xpert MTB/RIF Assay for the Diagnosis of Pulmonary and Extrapulmonary TB in Adults and Children: Policy Update. Geneva: World Health Organization; 2013. Available from http://www.ncbi.nlm.nih.gov/books/NBK258608/
Lin HH, Dowdy D, Dye C, Murray M, Cohen T. The impact of new tuberculosis diagnostics on transmission: why context matters. Bull World Health Organ. 2012 Oct 1;90(10):739-747A. doi: 10.2471/BLT.11.101436. Epub 2012 Jul 16.
Steingart KR, Schiller I, Horne DJ, Pai M, Boehme CC, Dendukuri N. Xpert(R) MTB/RIF assay for pulmonary tuberculosis and rifampicin resistance in adults. Cochrane Database Syst Rev. 2014 Jan 21;2014(1):CD009593. doi: 10.1002/14651858.CD009593.pub3.
Mase SR, Ramsay A, Ng V, Henry M, Hopewell PC, Cunningham J, Urbanczik R, Perkins MD, Aziz MA, Pai M. Yield of serial sputum specimen examinations in the diagnosis of pulmonary tuberculosis: a systematic review. Int J Tuberc Lung Dis. 2007 May;11(5):485-95.
Lombardi G, Di Gregori V, Girometti N, Tadolini M, Bisognin F, Dal Monte P. Diagnosis of smear-negative tuberculosis is greatly improved by Xpert MTB/RIF. PLoS One. 2017 Apr 21;12(4):e0176186. doi: 10.1371/journal.pone.0176186. eCollection 2017.
Ford I, Norrie J. Pragmatic Trials. N Engl J Med. 2016 Aug 4;375(5):454-63. doi: 10.1056/NEJMra1510059. No abstract available.
Rieder HL, Chiang CY, Rusen ID. A method to determine the utility of the third diagnostic and the second follow-up sputum smear examinations to diagnose tuberculosis cases and failures. Int J Tuberc Lung Dis. 2005 Apr;9(4):384-91.
Other Identifiers
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N202002038
Identifier Type: -
Identifier Source: org_study_id
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