The goal of this clinical trial is to compare the efficacy and safety of a Contezolid and Delamanid-Containing short regimen to standard longer regimen in Rifampicin-resistant pulmonary tuberculosis (RR-TB). The main questions it aims to answer are: * Is the efficacy of short regimen non-inferior to standard regimen? * Is the short regimen safe enough to replace the standard regimen? Participants will: * Be given with either short or standard regimen for RR-TB treatment * Be asked to complete the scheduled visit as planned.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
186
Oral, 400mg qd for 2 weeks, then 200 mg 3 times per week
Oral, 100mg bid
Oral, 800mg bid
Oral, 400mg qd for weight \<50kg, 600-750mg qd for weight ≥50kg
Oral, 400mg qd
Oral, 100mg qd
Oral, 600mg qd
Oral, 250mg bid
Oral, 600mg qd for weight \<50kg, 600-800mg qd for weight ≥50kg
Oral, 1500mg qd for weight \<50kg, 1750mg qd for weight ≥50kg
8000mg qd for weight \<50kg, 10000mg qd for weight ≥50kg
750mg qd for weight \<50kg, 1000mg qd for weight ≥50kg
Beijing Chest Hospital affiliated to Capital Medical University
Beijing, Beijing Municipality, China
Changsha Central Hospital
Changsha, China, China
Anhui Chest Hospital
Hefei, China, China
Jiamusi Tumor Hospital
Jiamusi, China, China
Shandong public health clinical center
Shandong, China, China
Favourable outcome rate at 24 months after randomization
The proportion of participants with a favourable outcome. A participant's outcome will be classified as favourable if their last two sputum culture results are negative unless they have previously been classified as unfavourable. These two cultures must be taken on separate visits (with ≥28d interval); the latest of which not being earlier than month 23 from randomization.
Time frame: from randomization to 24 months after
Unfavourable outcome rate at 24 months after randomization
Including 1. Death; 2. Treatment failure 3. Lost-to-follow-up 4. Treatment Discontinuation 5. Ttreatment prolonging 6. Still on treatment at the end of follow up 7. Recurrence
Time frame: from randomization to 24 months after
Time to culture conversion
Time from treatment initiation to first negative result in sputum culture confirmed by two consecutive cultures with an interval of ≥28d
Time frame: from randomization to 24 months after
Grade 3 or higher adverse event rate
Proportion of participants experiencing at least one grade 3 or higher adverse event, or serious adverse event defined by the Division of AIDS severity criteria for adverse events
Time frame: from randomization to 24 months after
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Xi'an Chest Hospital
Xi'an, China, China
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, China, China
Hebei Chest Hospital
Shijiazhuang, Hebei, China
Harbin Chest Hospital
Harbin, Heilongjiang, China
Infectious Disease Hospital of Hulunbuir
Hulunbuir, Inner Mongolia, China
...and 29 more locations