Tuberculosis, Pulmonary Clinical Trial
— ORIENTOfficial title:
Efficacy and Safety of Short-course Treatment for Drug-sensitive Tuberculosis in China
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.
Status | Recruiting |
Enrollment | 2442 |
Est. completion date | November 1, 2027 |
Est. primary completion date | October 1, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Guiyang Public Health Clinical Center | Guiyang | Guizhou |
China | People's Hospital of Qiandongnan | Kaili | Guizhou |
China | The Third People's Hospital of Liupanshui | Liupanshui | Guizhou |
China | Department of Infectious Disease, Huashan Hospital | Shanghai | Shanghai |
China | People's Hospital of Zhuji, Zhejiang Province | Zhuji | Zhejiang |
China | Affiliated Hospital of Zunyi Medical University | Zunyi | Guizhou |
Lead Sponsor | Collaborator |
---|---|
Huashan Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Treatment success rate of the short regimen during drug treatment and follow-up. | To compare the treatment success rate without relapse between the short regimen with rifapentine 10mg/kg, the short regimen with rifapentine 15mg/kg, the short regimen with rifapentine 20mg/kg and the WHO standardized regimen group. | 108 weeks after randomization | |
Secondary | The frequency of grade 3 or greater adverse events among patients Over the 108 Week Treatment and Follow-up Period. | To compare the proportion of patients who experience grade 3 or greater adverse events between the short regimen with rifapentine 10mg/kg, the short regimen with rifapentine 15mg/kg, the short regimen with rifapentine 20mg/kg and the WHO standardized regimen group. | up to 108 weeks | |
Secondary | Relapse rate during follow-up. | To compare the treatment success rate without relapse between the short regimen with rifapentine 10mg/kg, the short regimen with rifapentine 15mg/kg, the short regimen with rifapentine 20mg/kg and the WHO standardized regimen group. | 82-91 weeks after the end of drug treatment. | |
Secondary | the percentage of participants found to be culture-negative at the end of intensive phase and the end of treatment phase | To compare the percentage of participants found to be culture-negative at the end of intensive phase and the end of treatment phase between the short regimen with rifapentine 10mg/kg, the short regimen with rifapentine 15mg/kg, the short regimen with rifapentine 20mg/kg and the WHO standardized regimen group. | 8 weeks, 17 weeks and 26 weeks after randomization |
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