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A Multi-center clinical study on the midterm and long term result of a new treatment regimen for retreatment of pulmonary tuberculosis and it’s promotion

A Multi-center clinical study on the midterm and long term result of a new treatment regimen for retreatment of pulmonary tuberculosis and it’s promotion

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900021587
Enrollment
Unknown
Registered
2019-02-28
Start date
2019-03-01
Completion date
Unknown
Last updated
2019-03-04

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

Conditions

Tuberculosis

Interventions

High dose 1:4HL2EZLfx/4HL2E
High dose 2:6AmPaHMfxPtoPASZ/12PaHMfxPtoPAS(E)Z
High dose 3:6AmMfxPtoPASL2Z/12MfxPtoPAS(E)L2Z
High dose 4:4HL2EZLFX/4HL2E
standard dose 1:3HREZ/6HRE
standard dose 2:3HREZ/6HRE

Sponsors

Beijing Chest Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) The first retreatment; (2) Sputum Bacteriological Positive (sputum smear positive, or M.tb culture positive, or molecular biology positive); (3) Sputum negative (sputum smear negative and culture negative, see the definition of retreatment of tuberculosis with sputum negative); (4) Chest X-ray indicated tuberculosis with lung lesions; (5) Aged between 18 and 65 years old, male or female; (6) Normal liver and kidney function, as well as normal blood and urine test results; (7) Without Family history of drug-induced deafness; (8) No glaucoma and mental abnormalities, no epileptic seizures, non-pregnant women, no long-term use of immunosuppressive drugs, no complications of diabetes for diabetic TB patients; (9) Voluntary to be subjects and agree to sign the consent form.

Exclusion criteria

Exclusion criteria: (1) With active extra-pulmonary tuberculosis(concomitant tuberculous pleurisy is not excluded); (2) Non-tuberculous mycobacteria; (3) Severe allergy to study drug or any ingredient of it; (4) MDR-TB or XDR-TB in high dose gourp; (5) Isoniazid and/or rifampicin-resistant patients in control group; (6) Suffering from acute and chronic hepatitis, silicosis, moderate to severe anemia or blood disease, pulmonary heart disease, respiratory failure and heart failure, pregnancy, gastric ulcer, long-term alcoholism, cirrhosis, combined with HIV/AIDS, immune diseases, malignant tumors, metabolic diseases, diabetic complications (such as diabetic eye disease, diabetic nephropathy, diabetic peripheral neuritis, etc.), glaucoma and other eye diseases.

Design outcomes

Primary

MeasureTime frame
cure rate;default rate;relapse rate;treatment completion rate;failure rate;

Countries

China

Contacts

Public ContactGao Weiwei

Beijing Chest Hospital, Capital Medical University

gwwjys@sina.com+86 13520619966

Outcome results

None listed

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