Validation of a new high dose regimen for retreated pulmonary tuberculosis

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2100048701

Enrollment

Unknown

Registered

2021-07-13

Start date

2013-01-01

Completion date

Unknown

Last updated

2022-03-21

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

Conditions

tuberculosis

Interventions

experimental group 1:6 HEZ Lfx/6HELfx

experimental group 2:6 L2 E Z Lfx/6 E L2 Lfx

experimental group 3:4 H L2 E Z Lfx /4 H L2 E

control group 1 :2HREZS/6HRE

control group 2:3 H R E Z/6 H R E

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) The first retreatment; (2) Sputum smear Positive (sputum smear positive, or M.tb culture 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) 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.).

Design outcomes

Primary

Measure	Time frame
cure rate;default rate;relapse rate;treatment completion rate;failure 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