Health TrialsbyHealthPanel

Ultra-Short Regimen for Elderly DS-TB

ConditionPulmonary Tuberculosis
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Bedaquiline (B)

    Drug

    The initial dose of bedaquiline is 400 mg daily for 2 weeks, followed by 200 mg three times a week.

  • Sitafloxacin (S)

    Drug

    200mg once daily

  • Linezolid (L)

    Drug

    600mg once daily

  • Pyrazinamide (Z)

    Drug

    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)

    Drug

    4-6 mg/kg once daily, 300 mg once daily

  • Rifampicin (R)

    Drug

    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)

    Drug

    15-25 mg/kg once daily, 750 mg once daily

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Drug-susceptible TB (A)Experimental treatment 4 interventions
Group B: Drug-susceptible TB (B)Active comparator 4 interventions

Trial outcomes

Primary outcomes

1

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)
2

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)

Secondary outcomes

1

Sputum culture conversion rate

Time frame
2 months (9 weeks) after randomization
2

Serious adverse events or grade 3 or higher adverse events (short-term)

Time frame
12 months (52 weeks) after randomization
3

Serious adverse events or grade 3 or higher adverse events (mid-term)

Time frame
18 months (78 weeks) after randomization
4

Adverse events during treatment

Time frame
26 weeks

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: