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NCT05401071RecruitingPhase 2/3

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

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

Source: ClinicalTrials.gov · Last updated 11 Dec 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 2/3
Study type
Interventional
Enrollment
2442 (estimated)
First submitted
27 Feb 2022
Start date
13 Jan 2023
Primary completion date
1 Oct 2024
Lead sponsor
Huashan Hospital
Diseases
Tuberculosis
NCT number
NCT05401071

What you commit to

  • Study type: Interventional · Phase 2/3
  • Planned participants: 2442
  • From 13 Jan 2023 to the primary completion date, 1 Oct 2024
  • 6 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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;

Other illness

  • 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;

Lab values

  • 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;

Other

  • Alcohol abuse#drinking more than 64g of ethanol a day for male, 42g for female#;
  • AIDS patients;
  • Pregnant or breast-feeding.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 60 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (6)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Guiyang Public Health Clinical Center
Coordinator of this site? Confirm its status
GuiyangChinaNot yet recruiting
People's Hospital of Qiandongnan
Coordinator of this site? Confirm its status
KailiChinaNot yet recruiting
The Third People's Hospital of Liupanshui
Coordinator of this site? Confirm its status
LiupanshuiChinaNot yet recruiting
Department of Infectious Disease, Huashan Hospital
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting
People's Hospital of Zhuji, Zhejiang Province
Coordinator of this site? Confirm its status
ZhujiChinaNot yet recruiting
Affiliated Hospital of Zunyi Medical University
Coordinator of this site? Confirm its status
ZunyiChinaNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.