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Clinical evaluation of host gene related poor response tuberculosis and immunotherapy study (cohort study and randomized study)

Clinical evaluation of host gene related poor response tuberculosis and immunotherapy study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-INR-16009403
Enrollment
Unknown
Registered
2016-10-14
Start date
2017-06-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

tuberculosis

Interventions

poor response tuberculosis immunotherapy group:autologous DC immunotherapy and Anti-tuberculosis chemotherapy
poor response tuberculosis control group:Anti-tuberculosis chemotherapy
normal TB group:Anti-tuberculosis chemotherapy

Sponsors

Shanghai Public Health Clinical Center Affiliated to Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: cohort study: 1. First time treatment of tuberculosis, AFB positive, meet diagnostic criteria of Chinese TB guidelines; 2. Aged 18-65 years; 3. Have fixed address, can be followed up; 4. Written informed consent obtained. Randomized controlled trial: All above plus: Sputum AFB positive after 2 months Anti-TB chemotheraphy.

Exclusion criteria

Exclusion criteria: For cohort study and randomized study: 1. Do not meet Inclusion criteria; 2. Severe heart disease;severe malnutrition; immunosuppressive therapy; renal dysfunction; diabetes; 3. Severe side effect during TB treatment; 4. History of severe hypersensitivity/allergic shock; 5. Women during pregnancy and lactation; 6. Severe mental disease; 7. Any other situation that is considered not suitable for this study.

Design outcomes

Primary

MeasureTime frame
sputum AFB conversion time;

Secondary

MeasureTime frame
immune activity of T cell;

Countries

China

Contacts

Public ContactLu Shuihua

Shanghai Public Health Clinical Center Affiliated to Fudan University

tubercle@shaphc.org+86 18930811818

Outcome results

None listed

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