Pulmonary TuberculosisPhase 3Elderly-USRNCT07076225
Ultra-Short Regimen for Elderly DS-TB
A Phase 3 study testing Bedaquiline (B), Sitafloxacin (S) and Linezolid (L) in people with Pulmonary Tuberculosis, run by Shenzhen Third People's Hospital.
Trial 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). Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Pulmonary Tuberculosis
- What is being tested?
- Bedaquiline (B), Sitafloxacin (S) and Linezolid (L)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 25 Jul 2025to 31 Jul 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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;
- Willing to undergo HIV testing;
- Willing to preserve samples including DNA;
Who cannot join
- 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);
- Presence of non-tuberculous mycobacteria or other microbial lung infections that affect treatment outcomes;
- Simultaneously using drugs that affect the efficacy of this study or have contraindications for combination therapy;
Show all 16Show fewer
- Use of any immunosuppressive medication or systemic glucocorticoids for more than 2 weeks before screening;
- Any medication currently used or planned to be used that is known to significantly prolong the QTc interval, including but not limited to: amiodarone, amitriptyline, chloroquine, chlorpromazine, cisapride, dipyridamole, itraconazole, procaine, quinidine, or sotalol;
- Uncontrolled blood sugar in diabetes, with no likelihood of improving blood sugar status according to the judgment of the researchers;
- HIV positive;
- Coexisting with severe autoimmune diseases, severe liver and kidney dysfunction, psychiatric disorders, hematological disorders, or malignant tumors;
- Laboratory parameters within 14 days prior to recruitment: (1) Serum AST and ALT levels ≥ 3 times the upper limit of normal (ULN); (2) Blood creatinine ≥ 2 times ULN; (3) Hemoglobin ≤ 70 g/L; (4) Platelet count ≤ 50 × 10^9/L; (5) Blood potassium levels are ≥ 5.5 mmol/L or ≤ 3.5 mmol/L;
- ECG QTcF ≥450 ms (allowing for one re-test during the screening phase to reassess eligibility for inclusion); Presence of one or more risk factors that could cause QT interval prolongation, such as arrhythmia, myocardial ischemia, etc.; history or family history of long QT syndrome;
- Weight <30 kg, or ≥90 kg;
- The patient has participated in clinical trials of other drugs within the past 3 months during the screening period;
- Other conditions deemed unsuitable for participation in the study by the research doctors.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Ultrashort Regimen for Drug-susceptible Pulmonary Tuberculosis in Elderly Patients: A Multicenter Randomized Controlled 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.
- Conditions
- Pulmonary Tuberculosis
- Being tested
- Bedaquiline (B), Sitafloxacin (S), Linezolid (L), Pyrazinamide (Z), Isoniazid (H)
- Medical subject headings
- Tuberculosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Drug-susceptible TB (A) | Experimental | 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. Receives: Drug: Bedaquiline (B); Drug: Sitafloxacin (S); Drug: Linezolid (L); Drug: Pyrazinamide (Z) |
| Drug-susceptible TB (B) | Active comparator | 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. Receives: Drug: Pyrazinamide (Z); Drug: Isoniazid (H); Drug: Rifampicin (R); Drug: Ethambutol (E) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 2 months (9 weeks)
Secondary outcomes (6)
Sputum culture conversion rate
Measured: 2 months (9 weeks) after randomization
Serious adverse events or grade 3 or higher adverse events (short-term)
Measured: 12 months (52 weeks) after randomization
Serious adverse events or grade 3 or higher adverse events (mid-term)
Measured: 18 months (78 weeks) after randomization
Adverse events during treatment
Measured: 26 weeks
Percentage of patients with QTcF prolongation
Measured: 26 weeks
Percentage of Patients with liver function damage
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2025
- Study start25 Jul 2025 (estimated)
- Primary completion31 Jan 2030 (estimated)
- Study completion31 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary TuberculosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Third People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Chest Hospital, Capital Medical University, Fudan University, West China Hospital, Huazhong University of Science and Technology, Tsinghua University
- Responsible party
- Principal investigator, Shuihua Lu, Shenzhen Third People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07076225
- Sponsor's protocol ID
- USRElderly
- Acronym
- Elderly-USR
- Status last verified
- Jul 2025
- First submitted
- 30 Jun 2025
- Last updated
- 22 Jul 2025
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Paton NI, Cousins C, Suresh C, Burhan E, Chew KL, Dalay VB, Lu Q, Kusmiati T, Balanag VM, Lee SL, Ruslami R, Pokharkar Y, Djaharuddin I, Sugiri JJR, Veto RS, Sekaggya-Wiltshire C, Avihingsanon A, Sarin R, Papineni P, Nunn AJ, Crook AM; TRUNCATE-TB Trial Team. Treatment Strategy for Rifampin-Susceptible Tuberculosis. N Engl J Med. 2023 Mar 9;388(10):873-887. doi: 10.1056/NEJMoa2212537. Epub 2023 Feb 20.
PubMed 36808186
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Ultrashort Regimen for Drug-susceptible Pulmonary Tuberculosis in Elderly Patients: A Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07076225
- Acronym / sponsor ID
- Elderly-USR / USRElderly
- Conditions
- Pulmonary Tuberculosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Shenzhen Third People's HospitalUniversity, hospital or other
- Collaborators
- Beijing Chest Hospital, Capital Medical University, Fudan University, West China Hospital, Huazhong University of Science and Technology, Tsinghua University
- Study start
- 25 Jul 2025 (estimated)
- Primary completion
- 31 Jan 2030 (estimated)
- Study completion
- 31 Jul 2030 (estimated)
- First posted
- 22 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug-susceptible TB (A) | Experimental | Drug: Bedaquiline (B), Drug: Sitafloxacin (S), Drug: Linezolid (L), Drug: Pyrazinamide (Z)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-susceptible TB (B) | Active comparator | Drug: Pyrazinamide (Z), Drug: Isoniazid (H), Drug: Rifampicin (R), Drug: Ethambutol (E)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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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;
- Willing to undergo HIV testing;
Key exclusion criteria (16 listed)
- 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);
- Presence of non-tuberculous mycobacteria or other microbial lung infections that affect treatment outcomes;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bedaquiline (B)The initial dose of bedaquiline is 400 mg daily for 2 weeks, followed by 200 mg three times a week. | Drug | Drug-susceptible TB (A) |
| Sitafloxacin (S)200mg once daily | Drug | Drug-susceptible TB (A) |
| Linezolid (L)600mg once daily | Drug | Drug-susceptible TB (A) |
| 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. | Drug | Drug-susceptible TB (A), Drug-susceptible TB (B) |
| Isoniazid (H)4-6 mg/kg once daily, 300 mg once daily | Drug | Drug-susceptible TB (B) |
| 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. | Drug | Drug-susceptible TB (B) |
| Ethambutol (E)15-25 mg/kg once daily, 750 mg once daily | Drug | Drug-susceptible TB (B) |
Primary outcome
Unfavorable outcomes
Time frame: 12 months (52 weeks)
Percentage of patients with unfavorable outcomes (failure, treatment interruption, death, loss to follow-up, re-treatment, recurrence) at 12 months (52 weeks) after randomization
Percentage of patients with treatment interruption
Time frame: 2 months (9 weeks)
Percentage of patients who have treatment interruption due to any reason （including death）within 2 months (9 weeks) after randomization
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Results publication: PubMed 36808186Paton NI, Cousins C, Suresh C, Burhan E, Chew KL, Dalay VB, Lu Q, Kusmiati T, Balanag VM, Lee SL, Ruslami R, Pokharkar Y, Djaharuddin I, Sugiri JJR, Veto RS, Sekaggya-Wiltshire C, Avihingsanon A, Sarin R, Papineni P, Nunn AJ, Crook AM; TRUNCATE-TB Trial Team. Treatment Strategy for Rifampin-Susceptible Tuberculosis. N Engl J Med. 2023 Mar 9;388(10):873-887. doi: 10.1056/NEJMoa2212537. Epub 2023 Feb 20.
Related trials for Pulmonary Tuberculosis
Active, not recruitingObservational study
Mycobacterial and Opportunistic Infections in HIV-Negative Thai and Taiwanese Patients Associated With Autoantibodies to Interferon-gamma
Nontuberculous Mycobacteria, Mycobacterium Tuberculosis
RecruitingPhase 3
A Study of Quabodepistat-containing Regimens for the Treatment of Drug-resistant Pulmonary Tuberculosis
Rifampicin-Resistant Pulmonary Tuberculosis, Multidrug-Resistant Pulmonary Tuberculosis
RecruitingPhase 2
BRIGHT-Child TB: Short-Course Treatment for Non-Severe Pulmonary Tuberculosis in Children
Tuberculosis
Recruiting
Channa Striata and Curcuma Domestica Supplementation in Patients With Active Pulmonary Tuberculosis
Pulmonary Tuberculosis
RecruitingPhase 2
Trial of Novel Regimens for the Treatment of Pulmonary Tuberculosis
Pulmonary Tuberculosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Bedaquiline (B), Sitafloxacin (S) and Linezolid (L) in people with Pulmonary Tuberculosis, run by Shenzhen Third People's Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Professor Lu (+86 18930811818, lushuihua66@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unfavorable outcomes (time frame: 12 months (52 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07076225, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.