MDR/RR tuberculosis
Conditions
Interventions
Case series:Bedaquiline with background anti-tuberculosis drugs
Sponsors
Tuberculosis Department, Shanghai Public Health Clinical Center
Eligibility
Sex/Gender
Male
Age
6 Years to 18 Years
Inclusion criteria
Inclusion criteria: (1) Multi-drug resistant / rifampin-resistant tuberculosis patients with laboratory diagnosis; or laboratory tests are difficult to clarify drug resistance, but TB physicians highly suspect that they are drug-resistant based on the medical history of drug patients, such as close history Tuberculosis patients; (2) Drug resistance treatment has not been started, or treatment has been started but further intensive treatment is needed; (3) Aged 6 to 18 years old; children =16kg, children 12 years old and above must weigh >=31kg; (4) According to the principles of the WHO Integrated Guidelines for the Treatment of Drug-Resistant Tuberculosis and relevant guidelines in China, an effective treatment plan can be formed based on the results of drug sensitivity and previous treatment history; (5) No respiratory failure, no cardiac insufficiency and clinically significant arrhythmia performance, electrocardiogram QTcF<=450ms; (6) During the treatment and follow-up period, they can take the medicine according to the project requirements, complete the treatment monitoring, and report the adverse reactions to the responsible doctor in time; (7) No allergic constitution; (8) The patient and his legal guardian sign the corresponding informed consent.
Exclusion criteria
Exclusion criteria: 1. Contraindications for the use of bedaquinoline; 2. Those who participated in clinical trials of other unlisted new drugs within the past three months; 3. There is a history of high-risk cardiac comorbidities (such as ventricular arrhythmia, recent myocardial infarction, etc.), and one or more of the following risk factors that have led to prolonged QT interval have occurred: (1) The ECG showed a clear QT or QTc interval extension of more than or equal to 450ms during screening (allowing an unscheduled visit to be re-examined during the screening to re-evaluate the patient's eligibility); (2) Pathological Q wave (refers to Q wave greater than 40ms or depth greater than 0.4-0.5mV); (3) Evidence of ventricular pre-excitation (such as WolffParkinsonWhite syndrome); (4) There is evidence on the electrocardiogram that shows complete or clinically incomplete left bundle branch block or right bundle branch block; (5) Evidence of second or third degree heart block; (6) Indoor conduction delay, QRS duration is greater than 120ms; (7) Bradycardia, defined as a sinus heart rate less than 50bpm; (8) A personal or family history of long QT syndrome; (9) Personal history of heart disease, symptomatic or asymptomatic arrhythmia, except for sinus arrhythmia; (10) syncope (ie cardiogenic syncope, excluding syncope due to vasovagal nerve or epilepsy); (11) There are risk factors for developing torsades de pointes type ventricular tachycardia (such as heart failure, hypokalemia, or hypomagnesemia); 4. Those with extrapulmonary tuberculosis; 5. HIV positive or suffering from viral hepatitis; 6. The investigator believes that there is a situation that is not suitable for participating in this study (such as severe heart, liver, kidney and other dysfunction).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Side effects;Negative conversion rate of sputum smear and sputum culture; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes of drug sensitivity test results in patients with sputum culture not turning negative after 24 weeks of treatment; | — |
Countries
China
Contacts
Public ContactShuihua Lu
Shanghai Public Health Clinical Center
Outcome results
None listed