Tuberculosis
Conditions
Interventions
Sponsors
National Center for TB Control and Prevention, China CDC
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. 18~65 years of age; 2. Initially treating smear negative pulmonary tuberculosis patients. Smear negative pulmonary tuberculosis patients of those without any anti-TB drugs for treatment of tuberculosis, or have had irregular treatment, but less than 1 month; 3. local residents or resident population, can guarantee the completion of 4-6 months anti-TB treatment as well as 2-year follow-up examination after completion of treatment; 4. voluntarily signed informed consent to participate in and cooperate with the the study.
Exclusion criteria
Exclusion criteria: 1. Patient's with contraindications for cow Mycobacterium vaccae or anti-TB FDC; 2. Had a history of drug allergy, severe heart, liver, kidney, bone lesions, immune allergic diseases, epilepsy, neuro-psychiatric diseases, severe pulmonary bacterial or fungal infections; Complicated silicosis, diabetes, HIV/AIDS; 3. Severe tuberculosis, such as Miliary Tuberculosis, multiple lung cavity in patients with pulmonary tuberculosis, or complicated with tuberculous Pleurisy etc; 4. diagnosed with DR-TB or NTM before or during the study; 5. pregnant women, drug addicts; 6. peripheral white blood cells less than 3.0*10^9/L before treatment, liver and kidney dysfunction, fasting blood glucose higher than normal value; 7. Have used other immune preparations within the last 3 months; 8. patients with intellectual disabilities, deaf and disability who cannot cooperate with the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absorption rate of lung lesions by chest X-ray;Incidence of adverse reactions;relapse rate 6 months after treatment completion;relapse rate 1 year after treatment completion;relapse rae 2 years after treatment completion; | — |
Countries
China
Contacts
Public ContactShiming Cheng
Outcome results
None listed