Skip to content

A multicenter, randomized, double-blind, placebo-controlled clinical trial of a short-course prevention regimen (3HP) for people at high risk of tuberculosis

A multicenter, randomized, double-blind, placebo-controlled clinical trial of a short-course prevention regimen (3HP) for people at high risk of tuberculosis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036828
Enrollment
Unknown
Registered
2020-08-25
Start date
2021-01-01
Completion date
Unknown
Last updated
2020-09-21

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

Conditions

Latent tuberculosis infection

Interventions

Experimental group:INH/RFT
Control group:Placebo

Sponsors

Shanghai Public Health Clinical Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. aged 18 to 80 years old Male or female, weight>35Kg; 2. Voluntarily accept serum IGRA (including T-SPOt.TB and QFT-TB) or TST test, OR any one of the tests was positive in the past 3 months (TST requires indweling diameter greater than 10mm or blisters); 3. Willing to provide medical history information; 4. Informed consent obtained.

Exclusion criteria

Exclusion criteria: 1. With the following serious diseases, such as gastrointestinal tumor, acute or progressive liver disease, etc.; 2. Those who are participating in clinical trials for other new drugs or have participated in clinical trials for any other new drugs within 3 months prior to the clinical trials; 3. Persons with severe allergic constitution or family history of allergy;Persons with a history of allergy to two or more drugs; 4. Pregnant or breastfeeding women; 5. Patients with onset of mental illness; 6. Situations that the investigator believes not suitable for enrollment, such as very likely with poor compliance according to the evaluation; 7. Patients with active tuberculosis.

Design outcomes

Primary

MeasureTime frame
cumulative incidence in 2 years ;completion rate;

Secondary

MeasureTime frame
IGRA conversion rate;safety;

Countries

China

Contacts

Public ContactShuihua Lu

Shanghai Public Health Clinical Center

lushuihua66@126.com+86 021-37990333

Outcome results

None listed

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