Tuberculosis Research of INA-RESPOND On Drug Resistance
Tuberculosis Research of INA-RESPOND On Drug Resistance
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)
Inclusion Criteria:

 -  Patients suspected of having pulmonary TB

 -  Cough ≥ 2 weeks

 -  At least one other TB clinical symptom

 -  Fever

 -  Unexplained weight loss

 -  Loss of appetite

 -  Hemoptysis

 -  Shortness of breath

 -  Chest pain

 -  Night sweats

 -  Fatigue

 -  Suggestive TB on chest x-ray based on pulmonologist or internist consultant of
 pulmonology opinion

 -  Age ≥ 18 years' old

 -  Willing to be treated or evaluated at study site

 -  Willing to have specimens stored for use in future studies

 -  Patient denies having TB treatment for more than 7 days in the last 1 month (30 days).

 Exclusion Criteria:

 Pregnancy or any serious condition includes, but not limited to, liver disease, chronic
 kidney disease, and psychiatric illness that might interfere with study compliance (based
 on the clinician judgment).