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

ORIENT

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.

2023-01-13

2024-10-01

2027-11-01

Recruiting

Early phase I

2442

Inclusion Criteria: * 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. Exclusion Criteria: * Combined extrapulmonary tuberculosis; * Patients with extensive lesion (extent of disease greater than 50% or cavity size greater than 4cm) ; * Individuals will be excluded from enrollment if, at the time of enrollment, their M. tuberculosis isolate is already known to be resistant to any one or more of the following: rifampin, isoniazid, pyrazinamide, ethambutol, or fluoroquinolones; * Alcohol abuse#drinking more than 64g of ethanol a day for male, 42g for female#; * Hemoglobin is less than 70g/L or platelet is less than 100\*10\^9/L; * Patients with impaired liver function (hepatic encephalopathy, ascites; total bilirubin is higher than the upper limit of normal; Alanine aminotransferase or aspartate aminotransferase is higher than the upper limit of normal); * Blood creatinine is more than 1.5 times the upper limit of normal; * More than five days of systemic treatment with any one or more of the following drugs within 6 months preceding initiation of study drugs: isoniazid, rifampin, rifabutin, rifapentine, ethambutol, pyrazinamide, kanamycin, amikacin, streptomycin, capreomycin, moxifloxacin, levofloxacin, gatifloxacin, ofloxacin, ciprofloxacin, other fluoroquinolones, ethionamide, prothionamide, cycloserine, terizidone, para-aminosalicylic acid, linezolid, clofazimine, delamanid or bedaquiline; * Known history of prolonged QT syndrome; * Current or planned use within six months following enrollment of one or more of the following medications: HIV protease inhibitors, HIV integrase inhibitors, HIV entry and fusion inhibitors, HIV non-nucleoside reverse transcriptase inhibitors other than efavirenz; quinidine, procainamide, amiodarone, sotalol, disopyramide, ziprasidone, or terfenadine; * Known allergy or intolerance to any of the study medications; * AIDS patients; * Pregnant or breast-feeding.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 2442, 'type': 'ESTIMATED'}}

2023-12-11