Tests shorter tuberculosis treatment using higher-dose rifapentine
Tests a shorter rifapentine-based regimen in adults with drug-sensitive pulmonary tuberculosis.
Plain-language title generated from the registry record
Registry title: Optimizing(O) RIfapentine-based(RI) Regimen and shortENing(EN) the Treatment of Drug-sensitive Tuberculosis(T)
Key facts
- Where
- Guiyang, Kaili, Liupanshui, Shanghai, Zhuji, and Zunyi, ChinaSee the 6 sites
- Phase
- Phase 2/3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 60 years old?
Source: NCT05401071, who can take part
Where in China
- Guiyang Public Health Clinical CenterGuiyang, ChinaNot yet recruiting
- People's Hospital of QiandongnanKaili, ChinaNot yet recruiting
- The Third People's Hospital of LiupanshuiLiupanshui, ChinaNot yet recruiting
- Department of Infectious Disease, Huashan HospitalShanghai, ChinaTaking people
- People's Hospital of Zhuji, Zhejiang ProvinceZhuji, ChinaNot yet recruiting
- Affiliated Hospital of Zunyi Medical UniversityZunyi, ChinaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Huashan Hospital
- Trial code
- NCT05401071
- Record updated
- 11 December 2023
- Original description
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.Read full original descriptionShow less
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.
Inclusion: 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: 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; 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; 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; 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; Known history of prolonged QT syndrome; Alcohol abuse#drinking more than 64g of ethanol a day for male, 42g for female#; AIDS patients; Pregnant or breast-feeding.