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Clinical study of tuberculosis pill combined with 2HRZE/4HR regimen in the treatment of tuberculosis based on the real world

Clinical study of tuberculosis pill combined with 2HRZE/4HR regimen in the treatment of tuberculosis based on the real world

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200059178
Enrollment
Unknown
Registered
2022-04-26
Start date
2018-04-04
Completion date
Unknown
Last updated
2024-02-19

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

Conditions

tuberculosis

Interventions

Experimental group:Tuberculosis pill therapy
Control group:Conventional therapy

Sponsors

Guangzhou Chest Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

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

MeasureTime frame
Negative conversion rate of sputum bacteria;

Secondary

MeasureTime 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

Contacts

Public ContactTan Shouyong
13802930679@163.com+86 13802930679

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026