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Pulmonary TuberculosisPhase 3NCT06905522

A PAN-USR TB Multi-Center Trial

A Phase 3 study testing Bedaquiline (B), Sitafloxacin (S) and Linezolid (L) in people with Pulmonary Tuberculosis, run by Shenzhen Third People's Hospital at 3 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Tuberculosis (TB) remains a major public health issue and one of the top ten causes of death from a single infectious disease worldwide. China is among the countries with the highest TB burden, ranking third globally for total TB cases and second for drug-resistant TB cases. Read more about this study

Who is it for?
Ages 18 to 65 years
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
610 participants
Where
3 sitesChina
Study dates
18 Jun 2025to Dec 2029
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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age range from 18 to 65 years old, 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, whether resistant to rifampicin or not; 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;
  • For women with fertility, they have a negative serum or urine pregnancy test within 3 days before enroll the study and be willing to use effective contraceptive measures during the study period. Female subjects without fertility must have records of menopause, hysterectomy, bilateral oophorectomy, or bilateral tubal ligation. Acceptable forms of contraception include condoms, intrauterine devices, cervical caps with spermicides, and diaphragm with spermicides.

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, fluoroquinolones [including moxifloxacin, sitagliptin], pyrazinamide);
  • Resistance to any investigational drug (i.e., bedaquiline, linezolid, fluoroquinolones [including moxifloxacin, sitagliptin], pyrazinamide). 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;
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  • 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;
  • Women who are pregnant or breastfeeding;
  • 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

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Professor Lu contact

+86 18930811818

lushuihua66@126.com

China3 sites, 3 recruiting

  • Beijing Chest Hospital of Capital Medical University

    Beijing

    Nie Wenjuan, 010-8950-9331, 94642975@qq.com

    Recruiting

  • Shenzhen Third People's Hospital

    Shenzhen

    Lu Shunhua, 0755-6122-2333, lushuihua66@126.com

    Recruiting

  • The Sixth People's Hospital of the Xinjiang Uygur Autonomous Region

    Ürümqi

    Rukeyamu•Abudushalamu, 136-9996-9883, 969158537@qq.com

    Recruiting

Other trials in China

About this study

Official title: A Pan-Ultrashort Regimen for Drug-susceptible and Drug-resistant Pulmonary Tuberculosis: A Multi-Center Randomized Controlled Trial

Tuberculosis (TB) remains a major public health issue and one of the top ten causes of death from a single infectious disease worldwide. China is among the countries with the highest TB burden, ranking third globally for total TB cases and second for drug-resistant TB cases. PAN-TB is an innovative concept in TB treatment, aiming to develop a universal regimen effective for all forms of active TB, including both drug-susceptible and drug-resistant strains. The primary goal of the PAN-TB regimen is to simplify the treatment process, reduce costs, and improve treatment success rates. The ideal Target Regimen Profile (TRP) for PAN-TB includes superior efficacy compared to standard treatment for non-drug-resistant TB, a reduced treatment duration from the current 4-6 months to 2-3 months, and improved safety and tolerability. This project aims to explore a new ultra-short-course treatment regimen for both drug-sensitive (DS-TB) and drug-resistant TB (MDR/RR-TB), which aligns with the latest trends in TB treatment both domestically and internationally. The regimen also has significant practical implications for enhancing treatment efficacy and reducing patient burden. Furthermore, the study will explore the identification of new biomarkers closely linked to treatment outcomes over the course of full-cycle therapy.

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

  • Moxifloxacin (M)Drug

    400mg once daily

  • Pretomanid (Pa)Drug

    200mg once daily

Study groups in NCT06905522
Study groupRoleWhat they receive
Drug-susceptible TB (A1)Experimental2 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-resistant TB (A2)Experimental2 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 comparator2HRZE/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)
Drug-resistant TB (C)Active comparator6 months (26 weeks) of BPaLM: The treatment involves the use of bedaquiline (B), pretomanid (Pa), linezolid (L), and moxifloxacin (M) throughout the entire course. If the sputum culture remains positive at 4 months, or if clinical symptoms are not relieved by 6 months, or if chest CT results show worsening at 6 months, the treatment may be extended to 9 months. If the patient chooses to withdraw from the study at 6 months, they are allowed to do so.
Receives: Drug: Bedaquiline (B); Drug: Linezolid (L); Drug: Moxifloxacin (M); Drug: Pretomanid (Pa)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12 months (52 weeks)

  2. Safety

    Percentage of patients who have treatment interruption due to any reason or died within 2 months (9 weeks) after randomization

    Measured: 2 months (9 weeks)

Secondary outcomes (9)

  1. Sputum culture conversion rate

    Measured: 2 months (9 weeks) after randomization

  2. Unfavorable outcomes (short-term)

    Measured: 6 months (26 weeks) after randomization

  3. Unfavorable outcomes (mid-term)

    Measured: 18 months (78 weeks) after randomization

  4. Time to sputum culture conversion

    Measured: Median time

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

    Measured: 12 months (52 weeks) after randomization

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

    Measured: 18 months (78 weeks) after randomization

  7. Adverse events during treatment

    Measured: 9 or 13 weeks (A1, A2); 26 weeks (B, C)

  8. QTcF prolongation during treatment

    Measured: 9 or 13 weeks (A1, A2); 26 weeks (B, C)

  9. Liver function damage during treatment

    Measured: 9 or 13 weeks (A1, A2); 26 weeks (B, C)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2025
  2. Study start18 Jun 2025
  3. Primary completionJan 2029 (estimated)
  4. Study completionDec 2029 (estimated)

Resources

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
None (open label)
Enrolment
610 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06905522
Sponsor's protocol ID
SMART-C2405002
Status last verified
Nov 2025
First submitted
2 Jan 2025
Last updated
1 Dec 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

  • Conradie F, Bagdasaryan TR, Borisov S, Howell P, Mikiashvili L, Ngubane N, Samoilova A, Skornykova S, Tudor E, Variava E, Yablonskiy P, Everitt D, Wills GH, Sun E, Olugbosi M, Egizi E, Li M, Holsta A, Timm J, Bateson A, Crook AM, Fabiane SM, Hunt R, McHugh TD, Tweed CD, Foraida S, Mendel CM, Spigelman M; ZeNix Trial Team. Bedaquiline-Pretomanid-Linezolid Regimens for Drug-Resistant Tuberculosis. N Engl J Med. 2022 Sep 1;387(9):810-823. doi: 10.1056/NEJMoa2119430.

    PubMed 36053506

  • Nyang'wa BT, Berry C, Kazounis E, Motta I, Parpieva N, Tigay Z, Solodovnikova V, Liverko I, Moodliar R, Dodd M, Ngubane N, Rassool M, McHugh TD, Spigelman M, Moore DAJ, Ritmeijer K, du Cros P, Fielding K; TB-PRACTECAL Study Collaborators. A 24-Week, All-Oral Regimen for Rifampin-Resistant Tuberculosis. N Engl J Med. 2022 Dec 22;387(25):2331-2343. doi: 10.1056/NEJMoa2117166.

    PubMed 36546625

  • Nyang'wa BT, Berry C, Kazounis E, Motta I, Parpieva N, Tigay Z, Moodliar R, Dodd M, Solodovnikova V, Liverko I, Rajaram S, Rassool M, McHugh T, Spigelman M, Moore DA, Ritmeijer K, du Cros P, Fielding K; TB-PRACTECAL team. Short oral regimens for pulmonary rifampicin-resistant tuberculosis (TB-PRACTECAL): an open-label, randomised, controlled, phase 2B-3, multi-arm, multicentre, non-inferiority trial. Lancet Respir Med. 2024 Feb;12(2):117-128. doi: 10.1016/S2213-2600(23)00389-2. Epub 2023 Nov 16.

    PubMed 37980911

  • Zhang Y, Shi W, Zhang W, Mitchison D. Mechanisms of Pyrazinamide Action and Resistance. Microbiol Spectr. 2014 Aug;2(4):MGM2-0023-2013. doi: 10.1128/microbiolspec.MGM2-0023-2013.

    PubMed 26104205

  • Zhang Y, Chiu Chang K, Leung CC, Wai Yew W, Gicquel B, Fallows D, Kaplan G, Chaisson RE, Zhang W. 'Z(S)-MDR-TB' versus 'Z(R)-MDR-TB': improving treatment of MDR-TB by identifying pyrazinamide susceptibility. Emerg Microbes Infect. 2012 Jul;1(7):e5. doi: 10.1038/emi.2012.18. Epub 2012 Jul 25.

    PubMed 26038418

  • Fu L, Zhang X, Xiong J, Sun F, Weng T, Li Y, Zhang P, Li H, Yang Q, Cai Y, Liang H, Chen Q, Wang Z, Liu L, Chen X, Zhang W, Deng G. Selecting an appropriate all-oral short-course regimen for patients with multidrug-resistant or pre-extensive drug-resistant tuberculosis in China: A multicenter prospective cohort study. Int J Infect Dis. 2023 Oct;135:101-108. doi: 10.1016/j.ijid.2023.08.001. Epub 2023 Aug 10.

    PubMed 37567554

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 at 3 sites in China.

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 7 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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 NCT06905522, which also lists 7 linked publications.

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 1 Dec 2025.

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