pulmonary tuberculosis
Conditions
Interventions
short-course group:Bedaquiline for 1 month
control group:Levofloxacin for 6 months
Sponsors
Zhejiang Provincial Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Age
5 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >= 5 years old; 2.Index case confirmed as MDR/RR-TB or pre-XDR/XDR-TB by molecular or phenotypic drug susceptibility testing; 3.Having contact with the index case (>= 8 hours/day or 40 hours/week); 4.Positive IGRA result (QuantiFERON-TB Gold Plus >= 0.35 IU/ml); 5.Active pulmonary tuberculosis excluded by chest imaging; 6.Adequate function of major organs (ALT/AST = 60 ml/min, QTcF < 450 ms (for males) / < 470 ms (for females)); 7.Provision of written informed consent;
Exclusion criteria
Exclusion criteria: 1.Past or current active pulmonary tuberculosis; 2.Receipt of anti-tuberculosis treatment for >= 1 month within the past 6 months; 3.Known allergy to bedaquiline or levofloxacin; 4.First trimester of pregnancy (= 450/470 ms); 6.Clinically significant comorbidities, including but not limited to severe hepatic or renal impairment, arrhythmia, or epilepsy; 7.Participation in other interventional drug clinical trials within the past 3 months;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of tuberculosis; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse reactions (AEs);Individual compliance;Overall adherence; | — |
Countries
China
Contacts
Public ContactXiaomeng Wang
Zhejiang Provincial Center for Disease Control and Prevention
Outcome results
None listed