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Ultra-Short Regimen for Elderly DS-TB
Sponsor: Shenzhen Third People's Hospital
Summary
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.
Official title: A Ultrashort Regimen for Drug-susceptible Pulmonary Tuberculosis in Elderly Patients: A Multicenter Randomized Controlled Trial
Key Details
Gender
All
Age Range
65 Years - Any
Study Type
INTERVENTIONAL
Enrollment
300
Start Date
2025-07-25
Completion Date
2030-07-31
Last Updated
2025-07-22
Healthy Volunteers
No
Conditions
Interventions
Bedaquiline (B)
The initial dose of bedaquiline is 400 mg daily for 2 weeks, followed by 200 mg three times a week.
Sitafloxacin (S)
200mg once daily
Linezolid (L)
600mg once daily
Pyrazinamide (Z)
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.
Isoniazid (H)
4-6 mg/kg once daily, 300 mg once daily
Rifampicin (R)
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.
Ethambutol (E)
15-25 mg/kg once daily, 750 mg once daily