Actively Recruiting
Led by Huashan Hospital · Updated on 2023-12-11
2442
Participants Needed
6
Research Sites
160 weeks
Total Duration
Tuberculosis (TB) remains a leading infectious disease worldwide, with treatment challenges including poor adherence to long and complex regimens. Researchers are evaluating high-dose rifapentine regimens to treat rifampicin-sensitive pulmonary tuberculosis with the aim of shortening treatment duration and reducing side effects and economic burden. This multicenter, prospective, randomized controlled study focuses on assessing the safety, effectiveness, and pharmacokinetics/pharmacodynamics of these regimens compared to the standard treatment. The study includes four treatment groups: three experimental groups receiving rifapentine at doses of 10mg/kg, 15mg/kg, or 20mg/kg combined with isoniazid, pyrazinamide, and moxifloxacin during an 8-week intensive phase, followed by a continuation phase of 9 weeks with rifapentine, isoniazid, and moxifloxacin; and one comparator group receiving the World Health Organization's standard 26-week regimen with rifampicin, isoniazid, pyrazinamide, and ethambutol. The continuation phase may be extended up to 18 weeks if certain treatment response criteria are not met. Participants will be monitored through treatment and follow-up lasting up to 108 weeks after randomization. Researchers will evaluate treatment success rates, culture conversion at various time points, relapse rates, and adverse events throughout the study period. Safety assessments will include laboratory tests and clinical evaluations to monitor tolerability and drug effects, ensuring thorough observation during and after treatment completion.
CONDITIONS
Optimizing(O) RIfapentine-based(RI) Regimen and shortENing(EN) the Treatment of Drug-sensitive Tuberculosis(T)
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Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 17 to 26 weeks
Participants receive one of several drug regimens for drug-sensitive tuberculosis. Treatment includes an intensive phase of 8 weeks followed by a continuation phase of 9 weeks, with possible extension up to 18 weeks depending on smear conversion and cavity closure.
Weekly visits during intensive phase and biweekly visits during continuation phase
Duration - Up to 82 to 91 weeks after treatment ends
Participants are monitored after completing treatment to assess treatment success, safety, and relapse rates.
Periodic visits during follow-up phase
Total: 6 locations
1
Guiyang Public Health Clinical Center
Guiyang, Guizhou, China
Not Yet Recruiting
2
People's Hospital of Qiandongnan
Kaili, Guizhou, China
Not Yet Recruiting
3
The Third People's Hospital of Liupanshui
Liupanshui, Guizhou, China
Not Yet Recruiting
4
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, China
Not Yet Recruiting
5
Department of Infectious Disease, Huashan Hospital
Shanghai, Shanghai Municipality, China, 200040
Actively Recruiting
6
People's Hospital of Zhuji, Zhejiang Province
Zhuji, Zhejiang, China, 311899
Not Yet Recruiting
F
Feng Sun, Dr.
Y
Yang Li, Dr.
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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Zhen Feng, Yan Miao, Ying Peng...
https://pubmed.ncbi.nlm.nih.gov/37158831