Tuberculosis infection
Conditions
Interventions
Bedaquiline arm:Bedaquiline 200 mg orally once daily, to be taken with food at dinner, for a total of 28 days.
Levofloxacin arm:Levofloxacin 500 mg orally once daily for a total of 24 weeks.
Sponsors
The Third People’s Hospital of Shenzhen, Shenzhen, Guangdong, China
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >= 18 years, male or female; 2.Exclusion of active tuberculosis confirmed by etiological evidence or clinical diagnosis; 3.Close contact of an index case with confirmed rifampicin-resistant/multidrug-resistant (RR/MDR) active pulmonary tuberculosis, as determined by molecular drug resistance testing or phenotypic drug susceptibility testing of Mycobacterium tuberculosis; 4.Ability and willingness to adhere to the study medication regimen, complete treatment monitoring, and promptly report adverse events to the study physician throughout the preventive treatment and follow-up period.
Exclusion criteria
Exclusion criteria: 1.Patients with etiologically confirmed active pulmonary tuberculosis, clinically diagnosed active pulmonary tuberculosis, or suspected pulmonary tuberculosis (the diagnostic criteria for active tuberculosis in this study refer to the Health Industry Standard of the People's Republic of China "WS288-2017 Diagnosis of Pulmonary Tuberculosis"); 2.Known intolerance or allergy to bedaquiline or levofloxacin before enrollment; 3.Concurrent use of drugs with significant interactions with bedaquiline or levofloxacin (e.g., CYP3A4 inducers/inhibitors, lopinavir/ritonavir, nirmatrelvir/ritonavir, nevirapine, efavirenz, etc.). 4.Participation in other new drug clinical trials or participation in any other new drug clinical trial within 3 months before preventive treatment; 5.Electrocardiogram findings indicating any of the following:(1).QTcF interval (Ridericia's correction) >= 460 ms;(2).One or more risk factors for QT interval prolongation, including pathological Q waves (defined as Q waves > 40 ms or depth > 0.4–0.5 mV), ventricular pre-excitation, complete or clinically significant incomplete left or right bundle branch block, second- or third-degree heart block, intraventricular conduction delay with QRS duration > 120 ms, bradycardia defined as sinus rhythm = 2-fold increase in transaminases or bilirubin;(2).Renal function tests within 2 weeks showing elevated serum creatinine (>= 133 µmol/L or glomerular filtration rate < 90 mL/min);(3).Acute or allergic phase of any disease;(4).History of psychiatric disorders or epilepsy, or current use of antipsychotic medications;(5).Severe immunosuppression or advanced malignant tumors;(6).Poor adherence known before medication, with inability to complete the prescribed treatment course;(7).Previous history of tuberculosis with completion of standard anti-tuberculosis therapy within the past 2 years; 7.Diagnosed arrhythmias, congenital long QT syndrome, hypothyroidism, hypokalemia, or similar conditions; 8.Females planning pregnancy within the next 6 months, pregnant women, or breastfeeding women; 9.Any other condition considered by the investigator as unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparative Completion Rates of Two Preventive Treatment Regimens for Rifampicin-Resistant/Multidrug-Resistant Tuberculosis Infection in Adults;Proportion of Patients Experiencing Grade 3-4 Adverse Events from Initiation to Completion of Tuberculosis Infection Preventive Therapy.;Incidence of adverse events during the trial (including the incidence of systemic adverse reactions and the incidence of organic damage to individual organ systems).; | — |
Secondary
| Measure | Time frame |
|---|---|
| To Determine the Optimal Dosage of Bedaquiline for Preventing Rifampicin-Resistant/Multidrug-Resistant Tuberculosis Infection in Adults.; | — |
Countries
China
Contacts
Public ContactWeijian Liu
The Third People’s Hospital of Shenzhen, Shenzhen, Guangdong, China
Outcome results
None listed