Pulmonary Tuberculosis Confirmation by Culture Clinical Trial
Official title:
Xpert MTB/RIF Test as the Initial Diagnostic Test in the Diagnosis of Pulmonary Tuberculosis: a Pragmatic Trial
| Verified date | October 2021 |
| Source | Taipei Medical University WanFang Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 6900 |
| Est. completion date | December 31, 2022 |
| Est. primary completion date | October 31, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 20 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Taiwan | 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 | |
| Taiwan | Wan Fang Hospital, Taipei Medical University | Taipei |
| Lead Sponsor | Collaborator |
|---|---|
| Taipei Medical University WanFang Hospital | Buddhist Tzu Chi General Hospital, Chang-Hua Hospital, Chest Hospital, Ministry of Health and Welfare, Taiwan, Taichung Veterans General Hospital |
Taiwan,
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* Note: There are 18 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | performance of nucleic acid amplification test | sensitivity, specificity and predictive values of nucleic acid amplification test in the diagnosis of culture positive pulmonary TB | through study completion, an average of 1 year | |
| Other | incremental yield | 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 | through study completion, an average of 1 year | |
| Other | NAA false positive | The proportion of nucleic acid amplification test positive cases who were culture negative | through study completion, an average of 1 year | |
| Primary | diagnostic turnaround time | The interval between sputum examinations and initiation of ant-TB treatment | through study completion, an average of 1 year | |
| Secondary | culture positive pulmonary TB | The proportion of culture confirmed pulmonary TB among pulmonary TB cases notified | through study completion, an average of 1 year | |
| Secondary | change diagnosis | The proportion of TB patients who are advised to stop anti-TB treatment before completion of a treatment course | 12 months after the initiation of anti-tuberculosis treatment | |
| Secondary | 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 | 12 months after the initiation of anti-tuberculosis treatment |