Optimizing(O) RIfapentine-based(RI) Regimen and shortENing(EN) the Treatment of Drug-sensitive Tuberculosis(T)

Launched by HUASHAN HOSPITAL · May 28, 2022

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment approach for pulmonary tuberculosis (TB), which is a serious infectious disease. The study aims to find out if a higher dose of the medication rifapentine can effectively treat TB that responds to rifampicin while also shortening the treatment time to just 17 weeks. By making the treatment shorter and potentially easier to tolerate, the trial hopes to improve how patients stick to their treatment plans and reduce any side effects and costs associated with long-term therapy.

To participate in this trial, individuals need to be between 18 and 60 years old, weigh between 40 and 80 kg, and have a specific type of TB that is positive for bacteria. They must also be willing to provide consent for participation. Those with certain health issues, such as severe liver problems or other types of TB, will not be eligible. Participants can expect regular check-ins and monitoring during the study to assess how well the treatment works and how well they tolerate it. This trial is currently recruiting participants and could play an important role in improving TB treatment options in the future.

Gender

ALL

Eligibility criteria

• 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.