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Researchers are evaluating whether shorter treatment regimens are effective for people with asymptomatic tuberculosis. This phase 4, open-label, multicenter randomized controlled trial in China compares the standard 26-week treatment to shorter 17-week and 13-week regimens using different combinations and doses of anti-tuberculosis medications. The goal is to see if treatment duration can be safely reduced without increasing the medication types or doses. Participants will be randomly assigned to one of three groups: the standard regimen group, the four-month (17-week) regimen group, or the three-month (13-week) regimen group. The standard regimen involves 8 weeks of four drugs followed by 18 weeks of two drugs. The four-month group follows the same first 8 weeks, then 9 weeks of two drugs, with possible extension if sputum or imaging results suggest ongoing infection. The three-month group uses high-dose rifapentine, isoniazid, pyrazinamide, and moxifloxacin for 8 weeks, followed by 5 or 13 weeks of continuation treatment based on response, with dose adjustments allowed for intolerance. During the study, participants will be monitored for treatment response through sputum culture and radiological exams at the end of treatment phases. Researchers will measure the favorable outcome rate 78 weeks after randomization. The study includes safety monitoring, and treatment may be extended if infection indicators persist. Participants will be followed for over one year to assess long-term treatment success and safety.

Age: 14Years - 80YearsAll GendersPhase 4
5 locations
Clinical trials in Bijie | DecenTrialz