Tuberculosis
Conditions
Interventions
Sponsors
National Center for TB Control and Prevention, China CDC
Eligibility
Sex/Gender
All
Age
15 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Inclusion criteria for the follow-up of the 2014-2016 cohort: patients who could be followed up in the cohort built from 2014 to 2016; 2. Inclusion criteria for extending subjects from 2019: (1) aged 15 or above; (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. Patients who will be on the treatment regimen for more than 6 months, such as those with severe tuberculosis like Miliary Tuberculosis; 3. Patients with rifampic-resistant tuberculosis or non-tuberculosis mycobacterium that were diagnosed before or during the study; 4. Those who have used other immune preparations within the last 3 months; 5. Patients with intellectual disabilities, deaf and disability who cannot cooperate with the study. Contraindications to microcarb include: 1.those who have used microcard in the past and are allergic or have allergy constitution; 2.patients with severe heart disease, myocardial damage, significant vascular sclerosis, endocarditis, acute substantive hepatitis and other liver diseases with liver function damage; 3.pregnant women; 4.extremely weak and suffering from severe anemia; Contraindications to anti-tb FDC drugs include: 1. for rifampicin and pyrazinamide, isoniazid, ethambutol hydrochloride or allergy to any supplementary material; 2. patients with abnormal liver function, biliary tract obstruction, pregnant women within 3 months, gout patients, psychotic patients, epilepsy patients, diabetic patients with fundus lesions, porphyria; 3. patients with severe renal insufficiency.
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;relapse rae 3 years after treatment completion;relapse rae 4 years after treatment completion;relapse rae 5 years after treatment completion; | — |
Countries
China
Contacts
Public ContactLin Zhou
National Center for TB Control and Prevention, China CDC
Outcome results
None listed