A multicenter randomized controlled trial of a new short-term regimen containing betaquiline in the treatment of MDR-TB

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000029012

Enrollment

Unknown

Registered

2020-01-11

Start date

2020-02-15

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

tuberculosis

Interventions

experimental group:9 Lfx, Bdq, Lzd, Cfz and Cs

control group:6Lfx, Bdq, Lzd, Cfz and Cs /12 Lfx, 3 drugs of Cfz, Cs, Pto, Z, E

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patient signs the informed consent before the start of the study 2. Patients aged between 18 and 65 years,inclusive. 3. Patient with TB caused by isolated M. tuberculosis complex cnformed to resistant isoniazid and rifampicin or rifampicin by phenotype or molecular drug sensitivity test, and sensitive to fluoroquinolone. Chest X ray or CT showed active tuberculosis in lung; 4. No second-line antituberculosis drugs treatment or treatment less than 3 months; 5. Relevant laboratory tests were carried out before admission. ALT and total bilirubin were 2 times lower than the upper limit of normal value. The creatinine clearance rate (CrCl) was more than 30 ml / S / min. Hb is greater than 7.0 g /dl. Platelet was more than 50*10^9 / L; 6. Female patients of childbearing potential must have a negative urine pregnancy test and agree to take contraceptive measures during the research period.

Exclusion criteria

Exclusion criteria: 1. Combined with serious cardiovascular, liver, kidney, nervous system, blood system and other diseases, as well as combined with tumor diseases, the lesions are widely accompanied with respiratory insufficiency; 2. Diabetes, poor blood sugar control 3. HIV positive; 4. Patients with mental disorders; 5. QT interval prolongation > 450 ms; 6. Participants in other clinical trials; 7. Pregnant or lactating women; 8. Those who are allergic to the test drug or resistant to fluoroquinolone; those who are resistant to clofazimine 9. According to the judgment of the researcher, the subjects were combined with the patients who were not suitable to participate in the project or could not complete the whole treatment of the project.

Design outcomes

Primary

Measure	Time frame
Success rate;	—

Secondary

Measure	Time frame
Relapse rate;	—

Countries

China

Contacts

Public ContactMengqiu Gao

Beijing Chest Hospital, Capital Medical University

gaomqwdm@aliyun.com+86 13611009420

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026