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Discontinuation of ethambutol in pulmonary tuberculosis based on results of the MTBDRplus assay

Discontinuation of ethambutol in pulmonary tuberculosis based on results of the MTBDRplus assay

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CRIS
Registry ID
KCT0000610
Enrollment
800
Registered
2012-12-21
Start date
2012-11-20
Completion date
Unknown
Last updated
2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Randomization was centralized using an online, computer-generated randomization system before the MDRDRplus assay results are identified. Patients were stratified into two groups according to t

Sponsors

Asan Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Adult patients (= 18 years of age) (i) with culture-confirmed pulmonary TB or (ii) positive sputum acid-fast bacillus (AFB) smear with imaging findings consistent with pulmonary TB were included. We included patients who had not yet received treatment for TB or had been under treatment for less than two weeks.

Exclusion criteria

Exclusion criteria: Exclusion criteria were as follows: (i) history of TB resistant to INH and/or RIF; (ii) inability to receive standard four-drug treatment because of an underlying condition, such as liver or kidney disease; (iii) any condition that may prove fatal during the course of anti-TB treatment, such as advanced-stage cancer; (iv) combined extrapulmonary TB requiring prolonged treatment (e.g., TB meningitis, bone and joint TB); and (v) imaging findings compatible with typical findings of lung disease due to nontuberculous mycobacterium, despite a positive AFB smear in cases for which the AFB culture result was not yet available.

Design outcomes

Primary

MeasureTime frame
The proportion of patients who achieved treatment success at the end of treatment.

Secondary

MeasureTime frame
1-year recurrence

Countries

Korea, Republic of

Contacts

Public ContactTae Sun Shim

Asan Medical Center

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026