Actively Recruiting
Optimizing(O) RIfapentine-based(RI) Regimen and shortENing(EN) the Treatment of Drug-sensitive Tuberculosis(T)
Led by Huashan Hospital · Updated on 2023-12-11
2442
Participants Needed
6
Research Sites
250 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Optimizing(O) RIfapentine-based(RI) Regimen and shortENing(EN) the Treatment of Drug-sensitive Tuberculosis(T)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 to 60 years
- Weight between 40 to 80 kg
- Individuals with smear-positive pulmonary tuberculosis sensitive to rifampicin
- Willingness to provide signed informed consent, or parental consent and participant assent
- Non-menopausal women agree to use or have used effective contraception during treatment
You will not qualify if you...
- Combined extrapulmonary tuberculosis
- Extensive lesion with disease extent greater than 50% or cavity size greater than 4 cm
- Known resistance to rifampin, isoniazid, pyrazinamide, ethambutol, or fluoroquinolones
- Alcohol abuse exceeding 64g ethanol/day for males or 42g/day for females
- Hemoglobin less than 70 g/L or platelet count less than 100 x 10^9/L
- Impaired liver function including hepatic encephalopathy, ascites, or elevated liver enzymes
- Blood creatinine more than 1.5 times the upper limit of normal
- More than five days of systemic treatment with specified anti-TB drugs within 6 months before study
- Known history of prolonged QT syndrome
- Current or planned use of certain HIV and cardiac medications within six months after enrollment
- Known allergy or intolerance to any study medications
- AIDS patients
- Pregnant or breastfeeding
AI-Screening
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Trial Site Locations
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
Research Team
F
Feng Sun, Dr.
CONTACT
Y
Yang Li, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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