Health TrialsbyHealthPanel

A PAN-USR TB Multi-Center Trial

ConditionPulmonary Tuberculosis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-65
SponsorShenzhen Third People's Hospital

About this 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

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, 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);

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

  • Moxifloxacin (M)

    Drug

    400mg once daily

  • Pretomanid (Pa)

    Drug

    200mg once daily

Treatment groups

610 Participants
are divided into 4 treatment groups
Group A: Drug-susceptible TB (A1)Experimental treatment 4 interventions
Group B: Drug-resistant TB (A2)Experimental treatment 4 interventions
Group C: Drug-susceptible TB (B)Active comparator 4 interventions
Group D: Drug-resistant TB (C)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

Safety

Percentage of patients who have treatment interruption due to any reason or died 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

Unfavorable outcomes (short-term)

Time frame
6 months (26 weeks) after randomization
3

Unfavorable outcomes (mid-term)

Time frame
18 months (78 weeks) after randomization
4

Time to sputum culture conversion

Time frame
Median time

Other outcomes

Sponsors and contacts

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

Shenzhen Third People's Hospital

Lead sponsor

First Affiliated Hospital of Zhejiang University

Collaborator

Beijing Chest Hospital, Capital Medical University

Collaborator

Shenyang Tenth People's Hospital

Collaborator

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

Collaborator

The Fourth Hospital of Inner Mongolia Autonomous Region

Collaborator

Guizhou Aerospace Hospital

Collaborator

Source ClinicalTrials.gov
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