Tuberculosis Research of INA-RESPOND On Drug Resistance (TRIPOD)

Ina-Respond

Status: Completed

Conditions: MDR TB; Lung Tuberculosis

Treatments: Other: No Intervention

Study type: Observational

Funder types: Other

Identifiers

NCT02758236

INA102

U1111-1263-2311 (Other Identifier)

Details and patient eligibility

About

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.

Full 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:

   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)

Enrollment: 490 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design