Health Condition 1: A150- Tuberculosis of lung
Conditions
Interventions
Intervention1: RBIPMT: Four groups of 14 patients each with smear positive Rifampicin sensitive, pulmonary TB will be randomly allocated. Control group (Group 1) patients will be offered standard of c
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
Inclusion criteria: Clinical suspicion of pulmonary TB: persistent productive cough for >= 2 weeks Patient volunteers to give 2 sputum specimens over the course Age 18 years and above Willing and able to give valid informed written consent Patients free from any other disease or infection of lung such as Sarcoidosis COPD Lung Cancer etc
Exclusion criteria
Exclusion criteria: Known hypersensitivity to anti-TB drugs Patients with extra-pulmonary TB Patients with any other chronic pulmonary diseases Presence of secondary immunodeficiency states; organ transplantation diabetes mellitus malignancy treatment with corticosteroids Pregnancy and lactation Patients unlikely to comply with the treatment regimen
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of EBA will be 7 days measured by the daily rate of change of log10CFU in sputum (EBACFU0â??7). The slopes can be described by linear, bilinear, or multiple regression depending on which method fits the data best. Secondary endpoints include the EBACFU days 0â??2, EBACFU days 2â??7, EBACFU days 0â??7. EBATTP will be assessed in an analogous fashion from the daily prolongation of TTP over the relevant time period. Timepoint: The primary efficacy endpoint will be 1. the EBA over 7 days measured by the daily rate of change of log10CFU in sputum (EBACFU0â??7). The slopes can be described by linear, bilinear, or multiple regression depending on which method fits the data best. 2.Secondary endpoints include the EBACFU days 0â??2, EBACFU days 2â??7, EBACFU days 0â??7. 3.EBA TTP will be assessed in an analogous fashion from the daily prolongation of TTP over the relevant time period. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoints include the EBACFU days 0â??2, EBACFU days 2â??7, EBACFU days 0â??7. EBATTP will be assessed in an analogous fashion from the daily prolongation of TTP over the relevant time period. Timepoint: Secondary endpoints timepoint include the EBACFU at days 0â??2, EBACFU days at 2â??7, and at EBACFU days 0â??7. EBATTP will be assessed in an analogous fashion from the daily prolongation of TTP over the relevant time period. | — |
Countries
India
Contacts
Public ContactDr Urvashi B Singh
All India Institute of Medical Sciences
Outcome results
None listed