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Bedaquiline containing shorter regimens for the treatment on patients with MDR/RR-TB: multi-center, clinical trial in whole country

Bedaquiline containing shorter regimens for the treatment on patients with MDR/RR-TB: multi-center, clinical trial in whole country

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300073833
Enrollment
Unknown
Registered
2023-07-22
Start date
2023-08-01
Completion date
Unknown
Last updated
2023-07-25

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

Conditions

MDR/RR-TB

Interventions

treatment group:chemotherapy(containing BDQ)
control group:chemotherapy(BDQ free)

Sponsors

shanghai pulmonary hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: patients included meet criteria following below: ? hospitalized, confirmed as MDR/RR-TB, including children, adolescent, adult; ? Pulmonary tuberculosis patients with sputum culture positive, and DST indicating at least resistant to INH and RFP and resistant to FQs, or confirmed by Xpert MTB/RIF resistant to RFP; ? The patient has no previous medication history or has a history of using second-line treatment for no more than 1 month; ? Informed consent by participants;

Exclusion criteria

Exclusion criteria: patient with the following conditions were excluded from the study: ? with DM, HIV postive, immunosuppressive agents, and immun function abnormal ?cancer, silicosis, NTM infection, severe extrapulmonary TB and EBTB; ?pregnant, infant and elders; ? allergy to the drugs in the regiments or intolerance to any drugs in the regimens; ? identification as NTM infection; ? having severe renal or liver function abnormal or chronic hepatitis, having mental illness intolerant to any drugs in the regimens; ?having heart diseases, long QTs or can not be tolerant to any drug in the regiments ? be severe and not suitable for clinical trial; ? having be in the another clinical trial.

Design outcomes

Primary

MeasureTime frame
treatment success rate;culture conversation rate;

Countries

China

Contacts

Public Contactfanlin

Shanghai Pulmonary Hospital

1609556230@qq.com+86 139 1856 9516

Outcome results

None listed

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