Efficacy and Safety of Short-course Treatment for Drug-sensitive Tuberculosis in China

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Other, Combination product
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

Tuberculosis (TB) remains the most important infectious disease in the world. A major barrier to tuberculosis control is poor adherence to long-term and complex treatment regimens. This is a multicenter prospective, non-inferiority randomized controlled study. The purpose of our study is a) to evaluate the tolerability, efficacy and pharmacokinetics/pharmacodynamics (PK/PD) of the high-dose rifapentine, b) to evaluate whether the high-dose rifapentine-containing regimen has the potential to treat the rifampicin-sensitive pulmonary tuberculosis and shorten the course of treatment to 17 weeks. This study is of great significance for shortening the course of treatment, reducing the adverse reactions and economic burden of patients' treatment in rifampicin-sensitive tuberculosis patient.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• Age between 18 to 60 years;

• Weight between 40 to 80 kg;

• Individuals with smear-positive pulmonary tuberculosis and sensitive to rifampicin ;

• Willing to provide signed informed consent, or parental consent and participant assent.

• If you are a non-menopausal woman, agree to use or have used effective contraception during treatment.

Locations
Other Locations
China
Guiyang Public Health Clinical Center
NOT_YET_RECRUITING
Guiyang
People's Hospital of Qiandongnan
NOT_YET_RECRUITING
Kaili
The Third People's Hospital of Liupanshui
NOT_YET_RECRUITING
Liupanshui
Department of Infectious Disease, Huashan Hospital
RECRUITING
Shanghai
People's Hospital of Zhuji, Zhejiang Province
NOT_YET_RECRUITING
Zhuji
Affiliated Hospital of Zunyi Medical University
NOT_YET_RECRUITING
Zunyi
Contact Information
Primary
Feng Sun, Dr.
aaronsf1125@126.com
(086)15921403893
Backup
Yang Li, Dr.
y_li11@fudan.edu.cn
(086)18817583793
Time Frame
Start Date: 2023-01-13
Estimated Completion Date: 2027-11-01
Participants
Target number of participants: 2442
Treatments
Experimental: Short Regimen with Rifapentine 10mg/kg
Intervention: Short Regimen with Rifapentine 10mg/kg consists of two periods of 17- 26 weeks. The first is an intensive phase of 8 weeks, and included rifapentine, isoniazid, pyrazinamide, and moxifloxacin. This is followed by a continuation phase of 9 weeks with the following agents: rifapentine, isoniazid and moxifloxacin (extended up a maximum of 18 weeks if no smear conversion at the end of 8 weeks or the tuberculosis cavity is not closed at the end of 17 weeks).
Experimental: Short Regimen with Rifapentine 15mg/kg
Intervention: Short Regimen with Rifapentine 15mg/kg consists of two periods of 17- 26 weeks. The first is an intensive phase of 8 weeks, and included rifapentine, isoniazid, pyrazinamide, and moxifloxacin. This is followed by a continuation phase of 9 weeks with the following agents: rifapentine, isoniazid and moxifloxacin (extended up a maximum of 18 weeks if no smear conversion at the end of 8 weeks or the tuberculosis cavity is not closed at the end of 17 weeks).
Active_comparator: Standardized Regimen
Intervention:World Health Organization (WHO) Standardized Regimen group consists of 26 weeks with two phases of treatment. The first is an intensive phase of 8 weeks, and included rifampicin, isoniazid, pyrazinamide, and ethambutol. This is followed by a continuation phase of 18 weeks with the following agents: rifampicin and isoniazid.
Experimental: Short Regimen with Rifapentine 20mg/kg
Intervention: Short Regimen with Rifapentine 20mg/kg consists of two periods of 17- 26 weeks. The first is an intensive phase of 8 weeks, and included rifapentine, isoniazid, pyrazinamide, and moxifloxacin. This is followed by a continuation phase of 9 weeks with the following agents: rifapentine, isoniazid and moxifloxacin (extended up a maximum of 18 weeks if no smear conversion at the end of 8 weeks or the tuberculosis cavity is not closed at the end of 17 weeks).
Related Therapeutic Areas
Sponsors
Leads: Huashan Hospital

This content was sourced from clinicaltrials.gov