Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2025-12-24 @ 11:04 PM
NCT ID:
NCT06153069
Brief Summary:
This study is a randomized controlled trial among subclinical tuberculosis patients aiming to assess whether the standard treatment duration can be shortened to 17 weeks or even 8 weeks without changing the current anti-tuberculosis drugs or dosages.
Detailed Description:
This study is a prospective, open-label, multicenter randomized controlled trial. The randomization process employs central stratified block randomization to balance biases across different centers, initially stratified according to each participating center. Considering that radiological findings are crucial factors influencing treatment outcomes, the study will group patients based on the presence or absence of lesions in pulmonary imaging.
Subclinical tuberculosis patients included in the study will be randomly assigned in a 1:1 ratio to either the standard treatment group or the short-course treatment group. The standard treatment regimen consists of rifampicin (R), isoniazid (H), pyrazinamide (Z), and ethambutol (E) for 8 weeks, followed by rifampicin and isoniazid for an additional 18 weeks. The short-course treatment group follows the same regimen as the standard treatment group for the initial 8 weeks, and subsequent continuation treatment is determined based on the presence of radiological manifestations. Subclinical tuberculosis patients with radiological lesions will receive daily rifampicin and isoniazid for 9 weeks, resulting in a total treatment duration of 17 weeks. Those without radiological lesions will not undergo further continuation treatment, with a total treatment duration of 8 weeks.
Study:
NCT06153069
Study Brief:
Protocol Section:
NCT06153069