Refractory multi drug resistant tuberculosis
Conditions
Interventions
Experimental group:DC immunotherapy + short-term MDR-TB
control group:Short course MDR-TB chemotherapy
Sponsors
Shanghai Public Health Clinical Center
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: (1) MDR-TB patients based on laboratory diagnosis; (2) Aged >=18 years old; (3) According to the WHO treatment principle of MDR-TB, it is necessary to add beta quinoline to form an effective scheme; (4) The QTc of ECG was less than or equal to 450ms; (5) During the treatment and follow-up period, they can take medicine according to the project requirements, complete the treatment monitoring, and timely report the adverse reactions to the responsible doctors; (6) Sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Allergic history of bedaquoline; 2. Participants in clinical trials of other unlisted new drugs in the past three months; 3. Having a history of high-risk cardiac complications (such as ventricular arrhythmia, recent myocardial infarction, etc.), and having one or more of the following risk factors leading to QT prolongation: (1) ECG showed a definite QT or QTc interval extension of more than or equal to 450 ms during screening (re evaluation of subjects' qualification through an unscheduled visit during screening was allowed); (2) Pathological Q wave (refers to Q wave greater than 40 ms or depth greater than 0.4-0.5 MV); (3) Evidence of ventricular preexcitation (e.g., Wolff Parkinson white syndrome); (4) ECG showed incomplete left bundle branch block or right bundle branch block with clinical significance; (5) Evidence of degree II or III heart block; (6) The duration of QRS was more than 120ms; (7) Bradycardia was defined as sinus heart rate less than 50bpm; (8) Personal or family history of long QT syndrome; (9) Personal history of heart disease, symptomatic or asymptomatic arrhythmia, except sinus arrhythmia; (10) Syncope (i.e. cardiogenic syncope, excluding syncope caused by vasovagal nerve or epilepsy); (11) There are risk factors for torsade de pointe ventricular tachycardia (such as heart failure, hypokalemia or hypomagnesemia).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| symptom;Inflammatory indicators: White blood cell count, neutrophil count, lymphocyte count, erythrocyte sedimentation rate, C-reactive protein, etc.;Immune index;Symptoms and signs;The improvement of clinical symptoms and signs was observed; | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation index of sputum negative conversion;Changes of cavity in lesions; | — |
Countries
China
Contacts
Public ContactLu Xia
Shanghai Public Health Clinical Center
Outcome results
None listed