Ultra-Short Regimen for Elderly DS-TB

Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age65+
SponsorShenzhen Third People's Hospital

About this trial

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.

Eligibility criteria

Qualifiers

Aged 65 years or older, regardless of gender

Clinical symptoms and/or pulmonary imaging (chest X-ray or chest CT) support the diagnosis of active pulmonary tuberculosis;

Microbiological testing (molecular or phenotypic) confirms the presence of Mycobacterium tuberculosis, and susceptible to rifampicin; Recommend using respiratory specimens for GeneXpert MTB/RIF testing;

Voluntarily sign the informed consent form for participating in this project and be able and willing to accept follow-up visits;

Disqualifiers

Prior to this study, patients who were diagnosed with active pulmonary tuberculosis and had received anti-tuberculosis treatment (including first-line and second-line anti-tuberculosis drugs);

Intolerance or allergy to any investigational drug (i.e., bedaquiline, linezolid, pyrazinamide, etc);

Resistance to any investigational drug (i.e., bedaquiline, linezolid, pyrazinamide, etc). The following detection methods can be used: tNGS or other drug sensitivity testing methods (such as GeneXpert MTB/XDR, dissolution curve method, phenotypic drug sensitivity, etc.);

Suffering from hematogenous disseminated tuberculosis or coexisting with extrapulmonary tuberculosis (as specified in this study, the scope of pulmonary tuberculosis includes: simple pulmonary tuberculosis, pulmonary tuberculosis + tuberculous pleurisy/bronchial tuberculosis/mediastinal lymph node tuberculosis. Extrapulmonary tuberculosis refers to tuberculosis other than the chest-related types mentioned above);

Trial design

Treatments tested in this trial

  • Bedaquiline (B)
  • Sitafloxacin (S)
  • Linezolid (L)
  • Pyrazinamide (Z)
  • Isoniazid (H)
  • Rifampicin (R)
  • Ethambutol (E)

Treatment groups

300 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Shenzhen Third People's Hospital

Lead sponsor

Beijing Chest Hospital, Capital Medical University

Collaborator

Fudan University

Collaborator

West China Hospital

Collaborator

Huazhong University of Science and Technology

Collaborator

Tsinghua University

Collaborator