Randomized, comparative, multi-center clinical trial for new short therapeutic regimen including cycloserine for rifampicin-resistant tuberculosis treatment

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR1800018833

Enrollment

Unknown

Registered

2018-10-12

Start date

2018-01-01

Completion date

Unknown

Last updated

2018-10-15

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

Conditions

Tuberculosis

Interventions

A:8ZAm(Cm)Lfx(Mfx)CsPto/12ZLfx(Mfx)CsPto

B:4 (+) HZEAmMfxCfzPto/5ZEMfxCfz

C:4(+) CsZEAmMfxCfzPto/5ZEMfxCfz

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) First diagnosed, or accept first line anti-TB treatment less than 1 month; (2) Accept Informed Consent Form; (3) Aged 18-65 years; (4) Have rifampicin-resistance using molecular biology method; (5) Have lung lesion using Imaging; (6) Female patient pregnancy tests negative and accept contraception during study.

Exclusion criteria

Exclusion criteria: 1. Be allergic to therapeutic regimen; 2. Cr above 1.5 times or ALT/AST above 2.5 times; 3. Have aminoglycosides or fluoroquinolone resistance; 4. QTc above 500 millisecond; 5. Have serious cardiovascular disease including heart failure malignant hypertension myocardial infarction etc.; 6. Pregnant or lactation; 7. Karnofsky7.0%; 12. Have mental problem.

Design outcomes

Primary

Measure	Time frame
bacteriology;	—

Countries

China

Contacts

Public ContactNaihui Chu

Beijing Chest Hospital affiliated to Capital Medical University

chunaihui1994@sina.com+86 010 89509301

Outcome results

None listed

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