Latent tuberculosis infection
Conditions
Interventions
experimental group:Sim1907-05
control group:Isoniazid/rifapentine
Sponsors
Shanghai Public Health Clinical Center
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
| Measure | Time frame |
|---|---|
| cumulative incidence in 2 years;Treatment completion rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Treatment completion rate;safety; | — |
Contacts
Public ContactShuihua Lu
Shanghai Public Health Clinical Center
Outcome results
None listed