multidrug-resistant tuberculosis
Conditions
Interventions
Test group 1:bedaquiline, delamanid, linezolid and moxifloxacin combination regimen for 4 months
Test group 2:bedaquiline, delamanid, and linezolid combination regimen for 6 months
Sponsors
Shenzhen Third People's Hospital
Eligibility
Sex/Gender
All
Age
14 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Volunteer to participate in the research and sign the informed consent form; Or the guardian agrees that the child is the subject and signs the informed consent form; 2) Age >= 14 to = 30kg, male or female; 3) Chest CT showed the presence of pulmonary lesions, whether or not extensive pulmonary tuberculosis; It is allowed to have extrapulmonary tuberculosis at the same time, but it is necessary to exclude central nervous system tuberculosis, bone joint tuberculosis and miliary tuberculosis; 4) Within 3 months before screening, patients with rifampicin resistant tuberculosis were confirmed by sputum, induced sputum or GeneXpert MTB/RIF of alveolar lavage fluid; 5) Fluoroquinolones drug sensitivity results can be obtained before or within 2 months after enrollment, and rapid molecular testing or phenotypic drug sensitivity testing can be used; 6) Patients who are diagnosed as active pulmonary tuberculosis through clinical comprehensive evaluation and need anti tuberculosis treatment. Potential subjects include: a) new cases. b) Treatment failure cases (1. use of second-line anti tuberculosis drugs for more than 6 months and judged as treatment failure; 2. discontinuation of 2 or more drugs in the anti tuberculosis program for any reason and judged as treatment failure). c) Recurrent cases (endogenous relapse or exogenous reinfection). The clinical comprehensive evaluation should be given by the multi drug resistant tuberculosis expert group; 7) If a woman is of childbearing age, she needs to have a negative pregnancy urine test and agree to take effective contraceptive measures during the study period (including condoms, ligation, etc., drug contraception is not recommended); 8) It is expected that they will not leave the local area during the study period, and are willing to provide contact information to complete the treatment and follow-up arrangements.
Exclusion criteria
Exclusion criteria: 1) Non tuberculosis mycobacterium infection; 2) The single drug or any combination of bedazoline, pretomanid, delamanide or linezolid was used for more than one month before enrollment, and there is evidence of resistance to these drugs (confirmed by rapid molecular biology methods, whole genome sequencing, phenotypic in vitro drug sensitivity test and other methods); 3) Intolerance or allergy to the drugs in the treatment scheme before enrollment; 4) QTcF >= 450ms (a retest is allowed in the screening stage to re evaluate the eligibility); There are one or more risk factors causing QT interval extension, including pathological Q wave (defined as Q wave exceeding 40ms or depth exceeding 0.4-0.5mV), ventricular preexcitation, complete or clinically significant incomplete left bundle branch block or right bundle branch block, second or third degree cardiac conduction block, indoor conduction delay with QRS duration exceeding 120ms, and bradycardia with sinus heart rate below 50bpm, Personal or family history of long QT syndrome, history of heart disease, syncope (cardiac syncope, excluding syncope caused by vasovagal nerve or epilepsy), symptomatic or asymptomatic arrhythmia (except sinus arrhythmia), and risk factors of torsade de pointes ventricular tachycardia; 5) Hemoglobin is lower than 90g/L or platelet is lower than 75 * 10 ^ 9/L; 6) Impaired renal function (serum creatinine is 1.5 times higher than the upper limit of normal); 7) Impaired liver function (ALT and/or AST levels are 3 times higher than the upper normal limit), cirrhosis (Child grade B or C), or alcoholism; 8) Mental illness (epilepsy, severe depression, irritability or other psychosis); 9) Drug abuse; 10) Infection with human immunodeficiency virus (HIV) or immunodeficiency disease; 11) Malignant tumor; 12) For severe patients or other end-stage diseases, the estimated survival period is less than 6 months or Karnofsky score is less than 50%; 13) Pregnant or lactating women (unless the patient is willing to stop breastfeeding); 14) Subjects simultaneously use drugs that affect the efficacy observation of this study or have contraindications for combined use, including glucocorticoids, interferon, non steroidal anti-inflammatory drugs, monoamine oxidase inhibitors (phenethylhydrazine, isocarbazine, etc.), direct or indirect sympathomimetic drugs (such as pseudoephedrine), vasopressors (such as adrenaline, norepinephrine), dopamine drugs (such as dopamine, dobutamine) 5-hydroxytryptamine reuptake inhibitors, tricyclic antidepressants, 5-hydroxytryptamine 5-HTI receptor antagonists (amitriptyline, buspirone), pethidine, etc; 15) Currently participating in other clinical trials; 16) Other conditions determined by the investigator that the patient is not suitable to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Unfavorable outcome; | — |
Secondary
| Measure | Time frame |
|---|---|
| Sputum culture conversion proportion at month 2;Time to sputum culture conversion after treatment start;Incidence of Treatment Emergent Adverse Events (TEAEs) presented by incidence and seriousness, including grade 3 or greater AEs and serious adverse events (SAEs) of any grade by 9 months, as well as TB related or non-TB related death; | — |
Countries
China
Contacts
Public ContactFu Liang
Shenzhen Third People's Hospital
Outcome results
None listed