Safety and Effectiveness of Delamanid-containing Regimen for MDR-TB Patients in China
Multidrug Resistant Tuberculosis
About this trial
This is an interventional treatment trial for Multidrug Resistant Tuberculosis focused on measuring safety, Delamanid, effectiveness
Eligibility Criteria
Inclusion Criteria:
- Patients with microbiologically confirmed multidrug-resistant/rifampicin resistant tuberculosis ;
- Age 18 to 65 years old;
- MDR-TB treatment has not been started, or treatment has been started but treatment regimen need to be intensified;
- 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;
- No history of respiratory failure, no history of cardiac dysfunction and clinically significant arrhythmia, QTcF < 450ms;
- 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 ;
- Patients should sign the informed consent.
Exclusion Criteria:
- A history of allergy to nitroimidazole and pyrrole drugs such as Delamanid, metronidazole, tinidazole, or any excipient.
- 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.
- Taking strong CYP3A4 inducer drugs (such as carbamazepine).
- Is known to be pregnant (or planning to become pregnant) .
- Participants took part in trials of other new unlisted drugs within the past three months;
- Congenital QT interval prolongation is known or has any disease that may prolong the QT interval or QTc no less than 500 ms;
- A history of symptomatic arrhythmia or suffering from clinically related bradycardia;
- 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;
- Electrolyte disturbance, especially hypokalemia, hypocalcemia or hypomagnesemia;
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.
- Other drugs with protential cardiac risk : cisapride, haloperidol, domperidone, bepridil, diphemanil, probucol, dimepheptanol, methadone, vinblastine, arsenic trioxide.
Deletion criteria:
- Those who are found to have exclusion items after enrolled;
- 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);
- QTcF ≥500ms or clinically significant ventricular arrhythmia is confirmed;
- The expert group made decision that it is not appropriate for the patient to continue the treatment with Delamanid;
- 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;
- The patient requests dropout.
Sites / Locations
- Beijing Chest Hospital, Capital Medical University
- Changsha Central Hospital
- Public Health Clinical Center of Chengdu
- Chongqing Infectious Disease Medical Center
- Fuzhou Pulmonary Hospital of Fujian
- Guangzhou Chest Hospital
- Guiyang Public Health Clinical Center
- Heilongjiang Province center for tuberculosis Control and Prevention
- Hangzhou Red Cross Hospital
- Jiamusi Tumor Hospital
- Tuberculosis Hospital in Jilin Province
- Shandong Provincial Chest Hospital
- The Third People's Hospital of Kunming City
- Lanzhou Pulmonary Hospital
- Longtan Hospital of Guangxi Zhuang Autonomous Region
- Jiangxi Chest (Third People) Hospital
- Shanghai Pulmonary Hospital
- Hebei Chest Hospital
- The Fifth People Hospital of Suzhou
- The Fourth People's Hospital of Taiyuan
- Wuhan Institute For Tuberculosis Control
- Wuhan Jinyintan Hospital
- Xi'an Chest Hospital
- Shanxi Provincial Tuberculosis Institute
- Henan Provincial Chest Hospital
Arms of the Study
Arm 1
Experimental
delamanid containing regimen arm
the only one arm to be studied with delamid-containing regimen.