This study is a prospective observational cohort study of TB patients who are treated or evaluated at 10 study sites. Patients presenting with cough for 2 weeks or longer with at least one additional TB symptom and a chest X-ray suggestive of TB, will be invited to be enrolled in the study. The signed informed consent will designate their willingness to participate on this study.
This study is a prospective observational cohort study of TB patients who are treated or evaluated at 10 study sites. Patients presenting with cough for 2 weeks or longer with at least one additional TB symptom and a chest X-ray suggestive of TB, will be invited to be enrolled in the study. The signed informed consent will designate their willingness to participate on this study. Enrolled subjects will produce the sputum for bacteriological examination of M. tuberculosis by AFB, culture and Xpert. The sputum will also be tested by Xpert for drug resistance test. If the culture is positive, conventional DST will be performed, and M. tuberculosis isolates will be stored for spoligotyping and for future research on TB. All bacteriologicaly confirmed subjects will be followed for outcome assessment. For all enrolled subjects chest X-ray results, demographic data, TB co-morbidities, symptoms, nutritional status, treatment regimens, compliance and outcome will be collected. In addition, sputum, blood and urine will also be collected for storage. To estimate the proportion of MDR-TB amongst new and previously treated TB cases. 1. To evaluate accuracy of clinical diagnosis by comparing clinically defined TB to laboratory confirmed TB. 2. To compare AFB and Xpert MTB/RIF as TB diagnostic tests against culture result. 3. To estimate the sensitivity and specificity of Xpert MTB/RIF in detecting Rif susceptibility against DST. 4. To estimate the proportion of cured, completed, failed, died and lost to follow up as treatment outcomes on DS-TB and DR-TB cases 5. To evaluate the association of treatment success (cured or completed) with the following data: 1. Demographics (age, sex) 2. TB contact history 3. Smoking habit 4. Treatment seeking behavior 5. Co-morbidities (HIV, DM) 6. Primary and secondary drug resistance 7. Symptoms 8. Cavitary disease 9. Nutritional status 10. Treatment regimens 11. Patient reported compliance 12. Numbers of bacteria by AFB test 13. TB strains (e.g Beijing)
Study Type
OBSERVATIONAL
Enrollment
490
No Intervention
Site 520: University of Udayana/Sanglah Hospital
Denpasar, Bali, Indonesia
Site 560: University of Diponegoro/ Dr. Kariadi Hospital
Semarang, Central of Java, Indonesia
Site 590: Persahabatan Hospital
Jakarta, DKI Jakarta, Indonesia
Site 570: University of Airlangga/ Dr. Soetomo Hospital
Number of MDR TB Cases Amongst New TB Cases and Previously Treated TB Cases
AFB smear and GeneXpert were performed at the microbiology laboratory of the study site. Culture and drug susceptibility tests were conducted at appointed National TB Program Reference Laboratories.
Time frame: 2 months after enrollment
Number of Participants Who Were Cured, Failed, Died, Treatment Completion, and Lost to Follow-up
From 447 subjects with all sputum examination results, only 328 subjects confirmed by bacteriology and the treatment outcome were categorized as followed: 1. Cured 2. Failed 3. Died 4. Treatment completion 5. Lost to follow up
Time frame: 12- 30 months
Factors for Treatment Success.
Protective factors were collected by interview with the subjects. 237 subjects with confirmed bacteriologically and cured or complete treatment were analyzed for this outcome.
Time frame: 12-30 months
Factors of Treatment Interruption.
Risk factors of treatment interruption were collected by interview with the subject. 91 subjects were defined as lost to follow-up or treatment failure or died and analyzed for this outcome.
Time frame: 12-30 months
TB Case Category
TB category was defined as clinically TB or bacteriologically confirmed TB. 447 subjects with sputum examination were analyzed for this outcome.
Time frame: 12-30 months
The Performance of AFB and Xpert MTB/RIF
Assess the sensitivity and specificity of AFB and Xpert MTB/RIF to culture as gold standard. 312 subjects had positive sputum culture were used for evaluation of sensitivity. Meanwhile, 99 subjects that had no bacterial evidence of MTB infection (AFB, culture, and Xpert negative) and 36 subjects that were only AFB and/or Xpert MTB/RIF positive were used to evaluate the specificity. In total 135 subjects were analyzed to evaluate the specificity.
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Surabaya, East of Java, Indonesia
Site 600 : Adam Malik Hospital
Medan, North Sumatra, Indonesia
Site 550: University of Hassanudin/ Dr. Wahidin Sudirohusodo Hospital
Makassar, Indonesia
Site 580: University of Gadjah Mada/ Dr. Sardjito Hospital
Yogyakarta, Indonesia
Time frame: 12-30 months
The Performance of Xpert MTB/RIF
Assess the performance of Rifampicin susceptibility results in Xpert MTB/RIF against result in drug susceptible test (DST) as gold standard. 312 subjects had positive sputum culture were used to assess the performance of Xpert MTB/RIF. 196 subjects were sensitive to Rif in Xpert MTB/RIF. While 116 subjects had resistant to Rif in Xpert MTB/RIF.
Time frame: 12-30 months