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

Not Applicable

Recruiting

• Conditions: Certain infectious and parasitic diseases

• Registration Number: KCT0006891
• Lead Sponsor: Pusan National University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 4 April 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 583

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

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

Study & Design

• Study Type: Observational Study
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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