Asymptomatic TB With Innovative Modified Short-course Regimens
ConditionTuberculosis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age14-80
SponsorHuashan Hospital
About this trial
This study is a randomized controlled trial among asymptomatic tuberculosis individuals aiming to assess whether the standard treatment duration can be shortened to 17 weeks without increasing the types or doses of anti-tuberculosis medications or 13 weeks with the high-dose rifapentine and moxifloxacin.
Eligibility criteria
Qualifiers
1. Age between 14 to 80 years;
2. Male or female;
3. Willing to provide signed informed consent, or parental consent and participant assent;
4. Individuals with respiratory tract specimen (including sputum/bronchoalveolar lavage fluid/lung tissue) positive for acid-fast bacilli smear/culture/molecular amplification for M. tuberculosis;
Disqualifiers
1. Combined extrapulmonary tuberculosis;
2. Induviduals with extensive lesion (lesion involvement exceeding 50% or the aggregate diameter of all cavities exceeding 6 cm) ;
3. 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;
4. Individuals with impaired liver function (alanine transaminase [ALT] or total bilirubin [TBIL] more than 2.5 times the upper limit of normal) or combined with liver cirrhosis;
Trial design
Treatments tested in this trial
- Four-month regimen
- Three-month regimen
- Standard regimen
Treatment groups
426 Participants
are divided into 3 treatment groupsSponsors and collaborators
Huashan Hospital
Lead sponsor
University of Toronto
Collaborator
Source ClinicalTrials.gov