A randomized, controlled clinical study of local injection of anti-tuberculosis drugs into tuberculous cavities through transbronchial needle aspiration guided by bronchoscope

Status

Recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000037191

Enrollment

Unknown

Registered

2020-08-27

Start date

2020-09-01

Completion date

Unknown

Last updated

2020-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

tuberculosis

Interventions

experimental group:Local injection of isoniazid + amikacin into a tuberculous cavity by EBUS-GS technique and systemic antituberculosis therapy.

control group:Systemic antituberculosis therapy

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Newly treated tuberculosis patients aged 18-70 years; 2. Thin-section chest CT indicated that the maximum diameter of the cavity was >2cm, and the pulmonary tuberculosis cavity had clear drainage bronchus; 3. Blood routine, blood coagulation routine, blood gas, electrocardiogram and other indicators support bronchoscopy and treatment.

Exclusion criteria

Exclusion criteria: 1. Drug sensitivity test indicates patients with anti-TB drug resistance; 2. Elderly, pregnant or lactating women with diabetes or severe heart, liver, kidney or systemic diseases; 3. Patients receiving immunosuppressive agents; 4. Patients with contraindications in tracheoscopy; 5. Associated with pneumoconiosis or lung cancer.

Design outcomes

Primary

Measure	Time frame
Cavity diameter;Sputum negative conversion rate;	—

Countries

China

Contacts

Public ContactLiping Cheng

Shanghai Pulmonary Hospital affiliated to Tongji University

clptina99@163.com+86 13818125426

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026