Optimizing rifapentine treatment for drug-sensitive tuberculosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Department of Infectious Disease, Huashan Hospital
  Shanghai, Shanghai Municipality, China Recruiting
• 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
• 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.
• Email: aaronsf1125@126.com
• Phone: (086)15921403893

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.