NCT04433195

Brief Summary

Currently in Taiwan, most clinicians use sputum smear and culture for the diagnosis of pulmonary tuberculosis (TB) and apply nucleic acid amplification (NAA) test in a selected manner. In 2013, the World Health Organization issued conditional recommendation that Xpert MTB/RIF may be used rather than conventional microscopy and culture as the initial diagnostic test in all adults suspected of having TB. The newly published Taiwan guidelines for TB diagnosis and treatment has recommended NAA test, together with smear and culture, as the initial diagnostic test in individuals suspected of having TB. The investigators conduct a prospective study to investigate the use of Xpert MTB/RIF as the initial diagnostic test of pulmonary TB under a pragmatic trial design.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
6,900

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2020

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 9, 2020

Completed
6 days until next milestone

Study Start

First participant enrolled

June 15, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 16, 2020

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

May 12, 2022

Status Verified

October 1, 2021

Enrollment Period

1.4 years

First QC Date

June 9, 2020

Last Update Submit

May 10, 2022

Conditions

Pulmonary Tuberculosis Confirmation by Culture

Keywords

TuberculosisXpert MTB/RIFdiagnostic turnaround time

Outcome Measures

Primary Outcomes (1)

  • diagnostic turnaround time

    The interval between sputum examinations and initiation of ant-TB treatment

    through study completion, an average of 1 year

Secondary Outcomes (3)

  • culture positive pulmonary TB

    through study completion, an average of 1 year

  • change diagnosis

    12 months after the initiation of anti-tuberculosis treatment

  • treatment outcomes

    12 months after the initiation of anti-tuberculosis treatment

Other Outcomes (3)

  • performance of nucleic acid amplification test

    through study completion, an average of 1 year

  • incremental yield

    through study completion, an average of 1 year

  • NAA false positive

    through study completion, an average of 1 year

Study Arms (3)

Immediate NAA by clinician

ACTIVE COMPARATOR

Nucleic acid amplification test requested by clinicians as the initial diagnostic test for the diagnosis of pulmonary TB

Diagnostic Test: Xpert MTB/RIF test

Immediate NAA as intervention

EXPERIMENTAL

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)

Diagnostic Test: Xpert MTB/RIF test

No immediate NAA

NO INTERVENTION

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

Interventions

Xpert MTB/RIF testDIAGNOSTIC_TEST

Xpert MTB/RIF performed as the initial diagnostic test for the diagnosis of pulmonary TB

Also known as: nucleic acid amplification test
Immediate NAA as interventionImmediate NAA by clinician

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All presumptive tuberculosis cases who have sputum examinations for the diagnosis of pulmonary TB

You may not qualify if:

  • Tuberculosis cases who have been on treatment for 14 or more days who have sputum examinations for follow-up

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Chang-Hua Hospital

Chang-hua, 513, Taiwan

Location

Buddhist Tzu Chi General Hospital

Hualien City, Taiwan

Location

Taichung Veterans General Hospital

Taichung, Taiwan

Location

Chest Hospital, Ministry of Health and Welfare

Tainan, 717, Taiwan

Location

Wan Fang Hospital, Taipei Medical University

Taipei, 111, Taiwan

Location

Related Publications (18)

  • 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.

    PMID: 18371272RESULT

  • 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.

    PMID: 16158893RESULT

  • 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.

    PMID: 26527404RESULT

  • 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.

    PMID: 26679188RESULT

  • 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.

    PMID: 21507477RESULT

  • 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.

    PMID: 28804167RESULT

  • 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.

    PMID: 28222095RESULT

  • 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.

    PMID: 25423041RESULT

  • 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.

    PMID: 26930400RESULT

  • 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.

    PMID: 28063795RESULT

  • 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.

    PMID: 26792478RESULT

  • 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/

    PMID: 25473701RESULT

  • 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.

    PMID: 23109741RESULT

  • 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.

    PMID: 24448973RESULT

  • 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.

    PMID: 17439669RESULT

  • 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.

    PMID: 28430807RESULT

  • Ford I, Norrie J. Pragmatic Trials. N Engl J Med. 2016 Aug 4;375(5):454-63. doi: 10.1056/NEJMra1510059. No abstract available.

    PMID: 27518663RESULT

  • 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.

    PMID: 15830743RESULT

MeSH Terms

Conditions

Tuberculosis

Condition Hierarchy (Ancestors)

Mycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Study Officials

  • Chen-Yuan Chiang, MD,DrPhilos

    Wan Fang Hospital, Taipei Medical University, Taiwan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
both care providers and participants will be informed of positive results of Xpert MTB/RIF test
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: pragmatic trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2020

First Posted

June 16, 2020

Study Start

June 15, 2020

Primary Completion

October 31, 2021

Study Completion

December 31, 2022

Last Updated

May 12, 2022

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will share

individual participant data will be available on request for researchers who meet the criteria for access to confidential data

Shared Documents
STUDY PROTOCOL
Time Frame
1 year after publication of findings
Access Criteria
researchers who have been trained for research, are interested in diagnostic turnaround time of pulmonary TB, and will not use the data for commercial or publication purpose.

Locations

TW(5)