This is an investigational, prospective, multicenter, single-arm, open label trial. The goal of this clinical trial is to evaluate the efficacy and safety of a 6-month all-oral regimen, consisting of Bedaquiline (BDQ, B), Delamanid (DLM, D), Linezolid (LZD, L), Levofloxacin (LFX) or Clofazimine (CFZ, C), or BDLLfxC regimen, to treat rifampin-resistant pulmonary tuberculosis (RR-TB) in Chinese teenagers and adults (aged 12 years or above). The main questions it aims to answer are: * Is BDLLfxC regimen effective to treat RR-TB in Chinese participants? * Is BDLLfxC regimen safe in Chinese RR-TB participants? Participants will take BDLLfxC regimen to treat their RR-TB. There will be no additional hospital visits, laboratory tests or radiological examinations other than routine clinical practice.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
120
400 milligrams (mg) daily for 2 weeks(w), then 200mg three times a week for 22 weeks (w)
* for participants weighing up to 33.9 kilograms (kg): 50mg two times a day for 24w * for participants weighing 34kg or above: 100mg two times a day for 8w, then 200mg daily for 16w
* for participants weighing up to 33.9kg: 450mg daily; * for participants weighing 34kg or above: 600mg daily; for 24w if a negative culture is obtained from sputum collected at 16w, or else for 36w
Only for participants with confirmed fluoroquinolone-susceptible TB or unknown fluoroquinolone susceptibility: * for participants weighing up to 33.9kg: 500mg daily * for participants weighing 34kg to 49.9kg: 750 daily * for participants weighing 50kg or above: 1000mg daily for 24w if a negative culture is obtained from sputum collected at 16w, or else for 36w
Only for participants with confirmed fluoroquinolone-resistant TB or unknown fluoroquinolone susceptibility: 100mg daily, for 24w if a negative culture is obtained from sputum collected at 16w, or else for 36w
Anhui Chest Hospital
Hefei, Anhui, China
The 8th Medical Center of Chinese PLA General Hospital
Beijing, Beijing Municipality, China
The First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
The Fourth People's Hospital of Nanning
Nanning, Guangxi, China
Liupanshui Third People's Hospital
Liupanshui, Guizhou, China
Proportion of participants with favorable outcomes in both treatment and follow-up period
Favorable outcome in treatment period (up to 28 weeks after start of treatment): a participant's outcome will be defined as "favorable" if it meets any of the following below and has not been defined as "unfavorable" before, 1. . Cured: complete at least 80% of total required dose per protocol, with negative culture results of last two sputum samples (collected 14 days apart) ; 2. . Treatment completed: complete at least 80% of total required dose per protocol, with NO negative culture results of last two sputum samples (collected 14 days apart); Favorable outcome in follow-up period (from end of treatment to 72 weeks after start of treatment): a participant's outcome will be defined as "favorable" if it meets any of the following below and has not been defined as "unfavorable" before, (1). Cured: sputum culture negative at 72 weeks from start of treatment; (2). Culture negative when last seen: loss to follow-up before 72 weeks, with negative sputum culture when last seen.
Time frame: Up to 72 weeks after start of treatment
Proportion of participants with grade 3 or 4 adverse effect
Adverse effect will be graded using Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1.
Time frame: Up to 72 weeks after start of treatment
Proportion of participants with favorable outcomes in treatment period, follow-up period and prolonged follow-up period, respectively
The definitions of favorable outcome in treatment and follow-up period are as described in primary outcome. Favorable outcome in prolonged follow-up period (from end of treatment to 108 weeks after start of treatment): a participant's outcome will be defined as "favorable" if it meets any of the following below and has not been defined as "unfavorable" before, (1). Cured: sputum culture negative at 108 weeks from start of treatment; (2). Culture negative when last seen: loss to follow-up before 108 weeks, with negative sputum culture when last seen.
Time frame: Up to 108 weeks after start of treatment
Time to culture conversion
Time from start of treatment to the first time that obtained two consecutive negative sputum culture results, and the sputum samples must be collected 14 days apart. The date when first sputum sample is collected will be recorded as the date for culture conversion.
Time frame: Up to 72 weeks after start of treatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Hebei Chest Hospital
Shijiazhuang, Hebei, China
The Fifth Hospital of Shijiazhuang
Shijiazhuang, Hebei, China
Infectious Disease Hospital of Heilongjiang Province
Harbin, Heilongjiang, China
Jiamusi Tuberculosis Hospital(Jiamusi Cancer Hospital)
Jiamusi, Heilongjiang, China
Harbin Chest Hospital
Harbin, Helongjiang, China
...and 24 more locations