Status:
RECRUITING
Optimizing(O) RIfapentine-based(RI) Regimen and shortENing(EN) the Treatment of Drug-sensitive Tuberculosis(T)
Lead Sponsor:
Huashan Hospital
Conditions:
Tuberculosis, Pulmonary
Eligibility:
All Genders
18-60 years
Phase:
PHASE2
PHASE3
Brief Summary
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 multicen...
Detailed 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. Incomplete TB treat...
Eligibility Criteria
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
- 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.
Key Trial Info
Start Date :
January 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2027
Estimated Enrollment :
2442 Patients enrolled
Trial Details
Trial ID
NCT05401071
Start Date
January 13 2023
End Date
November 1 2027
Last Update
December 11 2023
Active Locations (6)
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1
Guiyang Public Health Clinical Center
Guiyang, Guizhou, China
2
People's Hospital of Qiandongnan
Kaili, Guizhou, China
3
The Third People's Hospital of Liupanshui
Liupanshui, Guizhou, China
4
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, China