A Phase 3 interventional study of Bedaquiline (B) and Sitafloxacin (S) in Pulmonary Tuberculosis, sponsored by Shenzhen Third People's Hospital. Not yet recruiting. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-07-22.
Sponsored by Shenzhen Third People's Hospital · Phase 3, Interventional, and Treatment
Tuberculosis (TB) remains one of the leading global public health concerns and is among the top ten causes of death from a single infectious agent. China ranks third worldwide in total TB burden, with a substantial proportion of cases classified as drug-susceptible TB (DS-TB). Despite the availability of effective standard treatment regimens, the current 6-month therapy duration poses challenges in terms of patient adherence, resource allocation, and overall treatment success.
In recent years, ultrashort-course regimens for DS-TB have been proposed and evaluated in clinical studies, showing promising results in improving adherence, reducing treatment duration, and maintaining or even enhancing treatment efficacy. However, these regimens have primarily been studied in younger populations, with limited data available for elderly patients. Older adults often present with age-related physiological changes, multiple comorbidities, and an increased risk of adverse drug reactions, which may affect both the efficacy and safety of treatment.
Therefore, this study aims to assess the therapeutic effectiveness and safety profile of a novel ultrashort-course regimen for drug-susceptible pulmonary TB specifically in patients aged 65 years and older.
Exclusion criteria:
2 months (9 weeks) BLSZ regimen: The treatment involves the use of bedaquiline (B), linezolid (L), sitafloxacin (S), and pyrazinamide (Z) throughout the entire process. At the end of 2 months (9 weeks) of treatment, if the sputum smear is still positive or if clinical symptoms have not improved, the treatment duration can be extended to 13 weeks. After the extended treatment period (3 months or 13 weeks), if the sputum smear remains positive or if clinical symptoms have not been relieved, the patient should be switched to the standard treatment regimen, and the subject should be withdrawn from the study.
Drug: Bedaquiline (B) · Drug: Sitafloxacin (S) · Drug: Linezolid (L) · Drug: Pyrazinamide (Z)
2HRZE/4HR (26 weeks): Four drugs-isoniazid (H), rifampicin (R), pyrazinamide (Z), and ethambutol (E)-are used during the first 2 months of the intensive phase. This is followed by 4 months of consolidation treatment, during which only isoniazid and rifampicin are used.
Drug: Pyrazinamide (Z) · Drug: Isoniazid (H) · Drug: Rifampicin (R) · Drug: Ethambutol (E)
The initial dose of bedaquiline is 400 mg daily for 2 weeks, followed by 200 mg three times a week.
200mg once daily
600mg once daily
20-30 mg/kg/day; 1000 mg for patients weighing \<50 kg, 1500 mg for patients weighing ≥50 kg but \<75 kg, and 2000 mg for patients weighing ≥75 kg.
4-6 mg/kg once daily, 300 mg once daily
8-12 mg/kg once daily, 450 mg for patients weighing \<50 kg, 600 mg for patients weighing ≥50 kg but \<75 kg, and 750 mg for patients weighing ≥75 kg.
15-25 mg/kg once daily, 750 mg once daily
Unfavorable outcomes
Percentage of patients with unfavorable outcomes (failure, treatment interruption, death, loss to follow-up, re-treatment, recurrence) at 12 months (52 weeks) after randomization
Time frame: 12 months (52 weeks)
Percentage of patients with treatment interruption
Percentage of patients who have treatment interruption due to any reason (including death)within 2 months (9 weeks) after randomization
Time frame: 2 months (9 weeks)
Sputum culture conversion rate
Time frame: 2 months (9 weeks) after randomization
Serious adverse events or grade 3 or higher adverse events (short-term)
Time frame: 12 months (52 weeks) after randomization
Serious adverse events or grade 3 or higher adverse events (mid-term)
Time frame: 18 months (78 weeks) after randomization
Adverse events during treatment
Time frame: 26 weeks
Percentage of patients with QTcF prolongation
Time frame: 26 weeks
Percentage of Patients with liver function damage
Time frame: 26 weeks
No study locations are listed for this record.
This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Shenzhen Third People's Hospital