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Efficacy and Safety of Immunotherapeutic Intervention with Weika(Mycobacterium vaccae) as an Adjunct to Short-Course Regimen for Initial Treatment of Smear-Negative Pulmonary Tuberculosis

Efficacy and Safety of Immunotherapeutic Intervention with Weika(Mycobacterium vaccae) as an Adjunct to Short-Course Regimen for Initial Treatment of Smear-Negative Pulmonary Tuberculosis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600119746
Enrollment
Unknown
Registered
2026-03-03
Start date
2024-12-21
Completion date
Unknown
Last updated
2026-03-09

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

Conditions

tuberculosis

Interventions

Experimental group:4-month short-course chemotherapy (2HRZE/2HR) Bovine tuberculosis immunotherapy
Control group:Standard 6-month chemotherapy (2HRZE/4HR)

Sponsors

Mianzhu People’s Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
15 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age 15–65 years; 2. Newly diagnosed pulmonary tuberculosis, sputum smear negative, positive for Mycobacterium tuberculosis complex by Xpert MTB/RIF test, and sensitive to rifampicin; 3. Never received anti-tuberculosis treatment; 4. Willing and able to comply with study visits, treatment regimen, laboratory tests, and 18-month follow-up; 5. Signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Diagnosed or suspected rifampicin-resistant tuberculosis or non-tuberculous mycobacterial disease; 2. Contraindications to Micard or any anti-tuberculosis FDC drugs (H, R, Z, E); 3. Severe pulmonary tuberculosis requiring a course longer than 6 months (such as miliary tuberculosis); 4. Use of other immunosuppressants within the past 3 months; 5. Presence of severe communication disorders or mental illness; 6. Women who are pregnant or breastfeeding.

Design outcomes

Primary

MeasureTime frame
cure rate;

Secondary

MeasureTime frame
1-year recurrence rate;CD4-positive T lymphocyte ;Immunoglobulin G;

Countries

China

Contacts

Public ContactWenqiu Deng

Mianzhu People’s Hospital

shiyangdong_cmc.edu.cn@outlook.com+86 136 8964 5829

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 14, 2026