Safety and Effectiveness of Delamanid-containing Regimen for MDR-TB Patients in China

Inclusion Criteria: 1. Patients with microbiologically confirmed multidrug-resistant/rifampicin resistant tuberculosis ; 2. Age 18 to 65 years old; 3. MDR-TB treatment has not been started, or treatment has been started but treatment regimen need to be intensified; 4. According to the guidelines of WHO's consolidated guidelines for the treatment of drug-resistant TB and the consensus of Chinese experts in the treatment of multidrug-resistant and rifampicin resistant TB (2019 edition), effective treatment regimens can only be formed by adding Delamanid based on the results of drug susceptibility testing and the previous treatment history; 5. No history of respiratory failure, no history of cardiac dysfunction and clinically significant arrhythmia, QTcF \< 450ms; 6. Patients should be able to take medicines and clinical monitoring according to the requirements of the trial during the treatment and follow-up phases, and adverse effects should be reported to the responsible doctor timely ; 7. Patients should sign the informed consent. Exclusion Criteria: 1. A history of allergy to nitroimidazole and pyrrole drugs such as Delamanid, metronidazole, tinidazole, or any excipient. 2. Serum transaminase increased ≥3 times the upper limit of normal value or total bilirubin increased ≥2.5 times the upper limit of normal, serum albumin \<2.8 g / dL, severe renal impairment. 3. Taking strong CYP3A4 inducer drugs (such as carbamazepine). 4. Is known to be pregnant (or planning to become pregnant) . 5. Participants took part in trials of other new unlisted drugs within the past three months; 6. Congenital QT interval prolongation is known or has any disease that may prolong the QT interval or QTc no less than 500 ms; 7. A history of symptomatic arrhythmia or suffering from clinically related bradycardia; 8. Any cardiac disease that can induce arrhythmias, such as severe hypertension, left ventricular hypertrophy (including hypertrophic cardiomyopathy), or congestive heart failure with reduced left ventricular ejection fraction; 9. Electrolyte disturbance, especially hypokalemia, hypocalcemia or hypomagnesemia; 10. Taking drugs known to prolong the QT interval such as the following drugs (but not limited to) : ① Anti-arrhythmic drugs, such as amiodarone, disopyramide, dofetilide, ibutilide, procainamide, quinidine, hydroquinidine, sotalol, etc .; * Antipsychotic drugs, such as phenothiazine, sertindole, sultopride, chlorpromazine, haloperidol, mesoridazine, pimozide or thioridazine, and antidepressants; ③ Certain antibiotics, including: * Macrolides, such as erythromycin, clarithromycin, etc ; * Moxifloxacin, Sparfloxacin; * Triazole antifungal drugs; * Spray him with amidine; * Saquinavir; ④ Some non-sedative antihistamines, such as terfenadine, astemizole, mizolastine, etc. 11. Other drugs with protential cardiac risk : cisapride, haloperidol, domperidone, bepridil, diphemanil, probucol, dimepheptanol, methadone, vinblastine, arsenic trioxide. Deletion criteria: 1. Those who are found to have exclusion items after enrolled; 2. Serious adverse reactions caused by Delamanid, such as allergic reactions, mental disorders, and liver injury (transaminases increase greater than 3 times the upper limit of normal value or total bilirubin increase greater than 2.5 times the upper limit of normal); 3. QTcF ≥500ms or clinically significant ventricular arrhythmia is confirmed; 4. The expert group made decision that it is not appropriate for the patient to continue the treatment with Delamanid; 5. The patient cannot tolerate the background treatment regimen, or the modified background treatment regimen cannot meet the 3 definitive sensitive drugs or 4 probably sensitive drugs; 6. The patient requests dropout.