Last updated on June 2018

Tuberculosis Research of INA-RESPOND On Drug Resistance


Brief description of 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.

Detailed Study Description

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
  6. Demographics (age, sex)
  7. TB contact history
  8. Smoking habit
  9. Treatment seeking behavior
  10. Co-morbidities (HIV, DM)
  11. Primary and secondary drug resistance
  12. Symptoms
  13. Cavitary disease
  14. Nutritional status
  15. Treatment regimens
  16. Patient reported compliance
  17. Numbers of bacteria by AFB test
  18. TB strains (e.g Beijing)

Clinical Study Identifier: NCT02758236

Contact Investigators or Research Sites near you

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dr. Bambang Sigit Riyanto, SpPD,K-P, ...

Site 580: University of Gadjah Mada/ Dr. Sardjito Hospital
Yogyakarta, Indonesia
2.51miles
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