RapTB - evaluation of techniques for tuberculosis diagnosis

Pragmatic clinical trial and cost-effectiveness evaluation of techniques for the sensitive and resistant tuberculosis diagnosis in patients assisted at two hospitals in Rio de Janeiro - Brazil

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN79888843

Enrollment

706

Registered

2010-01-07

Start date

2008-08-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tuberculosis Infections and Infestations Respiratory tuberculosis, not confirmed bacteriologically or histologically

Interventions

The diagnostic test used in the routine, the Löwenstein Jensen Proportion Method, will be compared to BACTEC™ MGIT™ 960 System.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Individuals aged 18 years or more, either sex 2. Assisted in two university hospitals in the southeast area of Brazil 3. Under tuberculosis suspicion (TB) 4. With or without anti-TB treatment in the past

Exclusion criteria

Exclusion criteria: Individuals who refuse to participate

Design outcomes

Primary

Measure	Time frame
Proportion of patients for whom medical procedure is changed after 60 days (stopping or initiating anti-TB drugs).	—

Secondary

Measure	Time frame
Patients will be followed for 180 days after randomisation. At the end of this period we will measure: 1. Number of participants lost to follow-up 2. Number of deaths by any cause in the patients included in the study 3. Number of adverse effects to the drugs 4. Proportion of patients with TB diagnosis sensitive or resistant to anti-TB drugs 5. Proportion of patients that undergo anti-TB treatment failure during the therapy 6. Proportion of drug resistant TB development in the patients 7. Time to sensitivity determination to drugs 8. Proportion of bacteriological conversion (bacilloscopy and culture for mycobacterium) due to the anti-TB treatment at the end of the second and sixth month of anti-TB treatment 9. Cost of the pulmonary TB diagnostic test, for each test, and for the anti-TB treatment 10. Cost of the resistant pulmonary TB diagnostic test for each test and for the anti-TB treatment 11. Cost for the patient and family nucleus in relation to the TB diagnosis 12. Cost for the public health system (SUS) in relation to the TB diagnosis 13. Proportion of necessary human resources for the accomplishment of the TB diagnostic test 14. Proportion of necessary human resources for the resistant TB diagnostic test	—

Measure

Time frame

Patients will be followed for 180 days after randomisation. At the end of this period we will measure: 1. Number of participants lost to follow-up 2. Number of deaths by any cause in the patients included in the study 3. Number of adverse effects to the drugs 4. Proportion of patients with TB diagnosis sensitive or resistant to anti-TB drugs 5. Proportion of patients that undergo anti-TB treatment failure during the therapy 6. Proportion of drug resistant TB development in the patients 7. Time to sensitivity determination to drugs 8. Proportion of bacteriological conversion (bacilloscopy and culture for mycobacterium) due to the anti-TB treatment at the end of the second and sixth month of anti-TB treatment 9. Cost of the pulmonary TB diagnostic test, for each test, and for the anti-TB treatment 10. Cost of the resistant pulmonary TB diagnostic test for each test and for the anti-TB treatment 11. Cost for the patient and family nucleus in relation to the TB diagnosis 12. Cost for the public health system (SUS) in relation to the TB diagnosis 13. Proportion of necessary human resources for the accomplishment of the TB diagnostic test 14. Proportion of necessary human resources for the resistant TB diagnostic test

—

Countries

Brazil

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 10, 2026