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A retrospective cohort study of bedaquiline-containing regimens with shorten all-oral therapy for multidrug-resistant tuberculosis

A retrospective cohort study of bedaquiline-containing regimens with shorten all-oral therapy for multidrug-resistant tuberculosis - BREATH-TB

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400093831
Enrollment
Unknown
Registered
2024-12-12
Start date
2024-11-20
Completion date
Unknown
Last updated
2024-12-16

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

Conditions

pulmonary tuberculosis

Interventions

BDQ-containing group:NA
BDQ-free group:NA

Sponsors

Huashan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age ranged from 18 to 75 years at the start of treatment record; 2. Newly diagnosed sputum smear-positive pulmonary tuberculosis with documented drug susceptibility test results confirming resistance to rifampicin and isoniazid; 3. Have discontinued the assigned treatment regimen since April 30, 2024.

Exclusion criteria

Exclusion criteria: 1. Bedaquiline was received for any reason before initiating MDR/RR-TB treatment; 2. Critical data are missing.

Design outcomes

Primary

MeasureTime frame
favorable outcome rate;—

Secondary

MeasureTime frame
incidence of grade 3 or higher adverse events;incidence of severe adverse events;incidence of adverse events leading to treatment discontinuation;Factors that may affect treatment outcomes;—

Countries

China

Contacts

Public ContactFeng Sun

Huashan Hospital, Fudan University

aaronsf1125@126.com+86 159 2140 3893

Outcome results

None listed

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