Optimizing rifapentine treatment for drug-sensitive tuberculosis

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

This study is testing a higher dose of rifapentine to see if it can effectively treat drug-sensitive tuberculosis in just 17 weeks, making it easier for patients to stick to their treatment.

Quick facts

• Phase: PHASE2; PHASE3
• Study type: Interventional
• Enrollment: 2442 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: Huashan Hospital (other)
• Locations: 6 sites (Guiyang, Guizhou and 5 other locations)
• Trial ID: NCT05401071 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates a high-dose rifapentine regimen aimed at treating rifampicin-sensitive pulmonary tuberculosis. It is a multicenter, non-inferiority randomized controlled study designed to assess the tolerability, efficacy, and pharmacokinetics of different doses of rifapentine. The study consists of two stages: the first stage focuses on selecting optimal doses based on patient response, while the second stage aims to confirm the efficacy and safety of these doses in a larger patient population. The goal is to shorten the treatment duration to 17 weeks, improving adherence and reducing the burden of tuberculosis treatment.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 60 with smear-positive pulmonary tuberculosis that is sensitive to rifampicin.

Not a fit: Patients with extensive lesions, extrapulmonary tuberculosis, or known drug-resistant tuberculosis strains may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could significantly shorten the treatment duration for patients with drug-sensitive tuberculosis, leading to better adherence and improved health outcomes.

How similar studies have performed: Other studies have explored shorter treatment regimens for tuberculosis, but this specific high-dose rifapentine approach is novel and has not been widely tested.

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.

Where this trial is running

Guiyang, Guizhou and 5 other locations

• Guiyang Public Health Clinical Center — Guiyang, Guizhou, China (NOT_YET_RECRUITING)
• People's Hospital of Qiandongnan — Kaili, Guizhou, China (NOT_YET_RECRUITING)
• The Third People's Hospital of Liupanshui — Liupanshui, Guizhou, China (NOT_YET_RECRUITING)
• Affiliated Hospital of Zunyi Medical University — Zunyi, Guizhou, China (NOT_YET_RECRUITING)
• Department of Infectious Disease, Huashan Hospital — Shanghai, Shanghai Municipality, China (RECRUITING)
• People's Hospital of Zhuji, Zhejiang Province — Zhuji, Zhejiang, China (NOT_YET_RECRUITING)

Study contacts

• Principal investigator: Wenhong Zhang, PhD. — Huashan Hospital of Fudan University，Shanghai，China
• Study coordinator: Feng Sun, Dr.

Conditions: Tuberculosis, Pulmonary, rifapentine, shorter treatment, pulmonary tuberculosis