tuberculosis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with newly treated mycopositive pulmonary tuberculosis (those who have not used antituberculosis drugs or have used antituberculosis drugs systematically for less than 1 month); 2. Included in DOTS administration under direct visual supervision of medical personnel; 3. Aged >= 18 years, no gender limit; 4. Fixed home address, willing to receive follow-up at any time, and willing to notify the research team of any change in address during treatment and follow-up; 5. The patient is informed, voluntarily signs the informed consent, and agrees to participate in all visits according to the requirements of the study protocol.
Exclusion criteria
Exclusion criteria: 1. Patients diagnosed by the researcher with serious diseases, serious organ lesions, mental illness, or other conditions that are not suitable for participation in this study; 2. Pregnant or planning for pregnancy; 3. Participated in or is participating in clinical trials of other drugs or medical devices within three months prior to the study; 4. Drug susceptibility test proves resistance to isoniazid or rifampicin; 5. Allergic to isoniazid, rifampicin, ethambutol and pyrazinamide.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Negative conversion rate of sputum bacteria; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in individual and total scores of clinical symptom grading at the end of treatment;Changes in individual and total quality-of-life scale scores from baseline at the end of treatment;Change from baseline in the proportion of the total population with holes at the end of follow-up;Incidence rate of adverse drug reactions; | — |
Countries
China