A study of bedaquiline for the treatment of latent tuberculosis

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300073791

Enrollment

Unknown

Registered

2023-07-20

Start date

2023-12-01

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

Latent tuberculosis

Interventions

Experimental group:The bedaquiline 2-week regimen

Control group:Isoniazid 9-month regimen

Eligibility

Sex/Gender

All

Age

18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Age above 18 years old, (2) Family contacts of confirmed drug-resistant tuberculosis cases, HIV patients, candidates for blood or solid organ transplantation, dialysis patients, and silicosis patients, (3) positive interferon release assay (IGRAs), (4) Self-signed informed consent.

Exclusion criteria

Exclusion criteria: (1) confirmed or suspected TB with recent anti-TB treatment, (2) a history of allergy to any of the experimental drugs, (3) a serum aspartate aminotransferase level 5 times the upper limit of the normal range, (4) pregnancy or lactation, (5) Severe arrhythmia requiring medical therapy, QTcF interval with fridericia >450ms, (6) history of apical torsion or risk factors, concomitant drugs to prolong QT/QTc interval.

Design outcomes

Primary

Measure	Time frame
Incidence of Tuberculosis;	—

Secondary

Measure	Time frame
The rate of adverse event;	—

Countries

China

Contacts

Public ContactKaijin Xu

The First Affiliated Hospital, College of Medicine, Zhejiang University

zdyxyxkj@zju.edu.cn+86 137 5087 0030

Outcome results

None listed

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