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Xpert MTB/RIF Test in the Diagnosis of Pulmonary Tuberculosis

Primary Purpose

Pulmonary Tuberculosis Confirmation by Culture

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Xpert MTB/RIF test
Sponsored by
Taipei Medical University WanFang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pulmonary Tuberculosis Confirmation by Culture focused on measuring Tuberculosis, Xpert MTB/RIF, diagnostic turnaround time

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Chang-Hua Hospital
  • Buddhist Tzu Chi General Hospital
  • Taichung Veterans General Hospital
  • Chest Hospital, Ministry of Health and Welfare
  • Wan Fang Hospital, Taipei Medical University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

No Intervention

Arm Label

Immediate NAA by clinician

Immediate NAA as intervention

No immediate NAA

Arm Description

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

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)

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

culture positive pulmonary TB
The proportion of culture confirmed pulmonary TB among pulmonary TB cases notified
change diagnosis
The proportion of TB patients who are advised to stop anti-TB treatment before completion of a treatment course
treatment outcomes
The proportion of patients who die before anti-TB treatment, who are successfully treated, who died during treatment, who are loss-to-follow-up, who have treatment failure and who are transferred out

Full Information

First Posted
June 9, 2020
Last Updated
May 10, 2022
Sponsor
Taipei Medical University WanFang Hospital
Collaborators
Buddhist Tzu Chi General Hospital, Chest Hospital, Ministry of Health and Welfare, Taiwan, Chang-Hua Hospital, Taichung Veterans General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04433195
Brief Title
Xpert MTB/RIF Test in the Diagnosis of Pulmonary Tuberculosis
Official Title
Xpert MTB/RIF Test as the Initial Diagnostic Test in the Diagnosis of Pulmonary Tuberculosis: a Pragmatic Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
June 15, 2020 (Actual)
Primary Completion Date
October 31, 2021 (Actual)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Taipei Medical University WanFang Hospital
Collaborators
Buddhist Tzu Chi General Hospital, Chest Hospital, Ministry of Health and Welfare, Taiwan, Chang-Hua Hospital, Taichung Veterans General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
In this study the investigators will respect current practice in the use of NAA in the diagnosis of pulmonary TB. Clinicians may have ordered NAA as the initial diagnostic test in adults suspected of having pulmonary TB (group A, Immediate NAA by clinician), and the investigators will not intervene. For patients who do not have NAA as the initial diagnostic test, the investigators will use random permuted blocks to randomize these participants into two groups. One group will have immediate Xpert test (intervention group) as the initial diagnostic test and another group will continue usual care without immediate Xpert test (control group). 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 The interval between sputum examinations and initiation of ant-TB treatment. The proportion of culture confirmed pulmonary TB among all pulmonary TB cases notified. The proportion of TB patients who are advised to stop anti-TB treatment before completion of a treatment course. 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 Performance (sensitivity, specificity and predictive values) of NAA in the diagnosis of culture positive pulmonary TB. 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. The proportion of NAA positive cases who were culture negative.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Tuberculosis Confirmation by Culture
Keywords
Tuberculosis, Xpert MTB/RIF, diagnostic turnaround time

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
pragmatic trial
Masking
None (Open Label)
Masking Description
both care providers and participants will be informed of positive results of Xpert MTB/RIF test
Allocation
Randomized
Enrollment
6900 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Immediate NAA by clinician
Arm Type
Active Comparator
Arm Description
Nucleic acid amplification test requested by clinicians as the initial diagnostic test for the diagnosis of pulmonary TB
Arm Title
Immediate NAA as intervention
Arm Type
Experimental
Arm Description
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)
Arm Title
No immediate NAA
Arm Type
No Intervention
Arm Description
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
Intervention Type
Diagnostic Test
Intervention Name(s)
Xpert MTB/RIF test
Other Intervention Name(s)
nucleic acid amplification test
Intervention Description
Xpert MTB/RIF performed as the initial diagnostic test for the diagnosis of pulmonary TB
Primary Outcome Measure Information:
Title
diagnostic turnaround time
Description
The interval between sputum examinations and initiation of ant-TB treatment
Time Frame
through study completion, an average of 1 year
Secondary Outcome Measure Information:
Title
culture positive pulmonary TB
Description
The proportion of culture confirmed pulmonary TB among pulmonary TB cases notified
Time Frame
through study completion, an average of 1 year
Title
change diagnosis
Description
The proportion of TB patients who are advised to stop anti-TB treatment before completion of a treatment course
Time Frame
12 months after the initiation of anti-tuberculosis treatment
Title
treatment outcomes
Description
The proportion of patients who die before anti-TB treatment, who are successfully treated, who died during treatment, who are loss-to-follow-up, who have treatment failure and who are transferred out
Time Frame
12 months after the initiation of anti-tuberculosis treatment
Other Pre-specified Outcome Measures:
Title
performance of nucleic acid amplification test
Description
sensitivity, specificity and predictive values of nucleic acid amplification test in the diagnosis of culture positive pulmonary TB
Time Frame
through study completion, an average of 1 year
Title
incremental yield
Description
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
Time Frame
through study completion, an average of 1 year
Title
NAA false positive
Description
The proportion of nucleic acid amplification test positive cases who were culture negative
Time Frame
through study completion, an average of 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All presumptive tuberculosis cases who have sputum examinations for the diagnosis of pulmonary TB Exclusion Criteria: Tuberculosis cases who have been on treatment for 14 or more days who have sputum examinations for follow-up
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chen-Yuan Chiang, MD,DrPhilos
Organizational Affiliation
Wan Fang Hospital, Taipei Medical University, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chang-Hua Hospital
City
Chang-Hua
ZIP/Postal Code
513
Country
Taiwan
Facility Name
Buddhist Tzu Chi General Hospital
City
Hualien City
Country
Taiwan
Facility Name
Taichung Veterans General Hospital
City
Taichung
Country
Taiwan
Facility Name
Chest Hospital, Ministry of Health and Welfare
City
Tainan
ZIP/Postal Code
717
Country
Taiwan
Facility Name
Wan Fang Hospital, Taipei Medical University
City
Taipei
ZIP/Postal Code
111
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
individual participant data will be available on request for researchers who meet the criteria for access to confidential data
IPD Sharing Time Frame
1 year after publication of findings
IPD Sharing 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.
Citations:
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Citation
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Learn more about this trial

Xpert MTB/RIF Test in the Diagnosis of Pulmonary Tuberculosis

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