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Clinical efficacy of QMAC-DST for rapid diagnosis of drug-resistant tuberculosis

Clinical efficacy of QMAC-DST for rapid diagnosis of drug-resistant tuberculosis: A multicenter, prospective study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0006891
Enrollment
583
Registered
2022-01-05
Start date
2022-01-21
Completion date
Unknown
Last updated
2022-04-04

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

Conditions

None listed

Interventions

None listed

Sponsors

Pusan National University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Adult male and female between the ages of 19 and 85 2) Respiratory tuberculosis (pulmonary tuberculosis, endobronchial tuberculosis, laryngeal tuberculosis) 3) Patients who have confirmed M. tuberculosis in sputum or bronchoscopic washing/BAL fluid(culture or TB-PCR) or clinically/radiologically suspected respiratory tuberculosis patients who starting or planning to start tuberculosis treatment (even if tuberculosis is not confirmed bacteriologically at the time of enrollment) 4) Patients who have started tuberculosis treatment for less than 2 weeks (14 days) as of the date of consent can participate in the study

Exclusion criteria

Exclusion criteria: 1) Patients who have already requested a conventional (existing) phenotype drug susceptibility test (M-kit DST) at the time of enrollment

Design outcomes

Primary

MeasureTime frame
Time to appropriate treatment in study subjects who changed TB drugs based on QMAC-DST results

Secondary

MeasureTime frame
Turn-around-time of QMAC-DST test;Proportion of subjects with TB drug change based on QMAC-DST results;time to sputum smear conversion;time to sputum culture conversion;Proportion and time to appropriate treatment of subjects who change TB drugs based on Molecular DST results

Countries

Korea, Republic of

Contacts

Public ContactJeongha Mok

Pusan National University Hospital

mokgamokga@gmail.com+82-51-240-7889

Outcome results

None listed

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