Multidrug Resistant Tuberculosis Clinical Trial
Official title:
Safety and Effectiveness of Delamanid-containing Regimen for Treatment of Patients With Multidrug-resistant Tuberculosis in China
Verified date | July 2022 |
Source | Beijing Chest Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to monitor and evaluate the safety and effectiveness of Delamanid in combination with an optimal background regimen (OBR) of anti-TB drugs for treatment of MDR-TB.
Status | Active, not recruiting |
Enrollment | 608 |
Est. completion date | July 16, 2024 |
Est. primary completion date | June 16, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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) : ? 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; ? Certain antibiotics, including: - Macrolides, such as erythromycin, clarithromycin, etc ; - Moxifloxacin, Sparfloxacin; - Triazole antifungal drugs; - Spray him with amidine; - Saquinavir; ? 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. |
Country | Name | City | State |
---|---|---|---|
China | Beijing Chest Hospital, Capital Medical University | Beijing | |
China | Changsha Central Hospital | Changsha | |
China | Public Health Clinical Center of Chengdu | Chengdu | |
China | Chongqing Infectious Disease Medical Center | Chongqing | |
China | Fuzhou Pulmonary Hospital of Fujian | Fuzhou | |
China | Guangzhou Chest Hospital | Guangzhou | |
China | Guiyang Public Health Clinical Center | Guiyang | |
China | Heilongjiang Province center for tuberculosis Control and Prevention | Haerbin | |
China | Hangzhou Red Cross Hospital | Hangzhou | |
China | Jiamusi Tumor Hospital | Jiamusi | |
China | Tuberculosis Hospital in Jilin Province | Jilin | |
China | Shandong Provincial Chest Hospital | Jinan | |
China | The Third People's Hospital of Kunming City | Kunming | |
China | Lanzhou Pulmonary Hospital | Lanzhou | |
China | Longtan Hospital of Guangxi Zhuang Autonomous Region | Liuzhou | |
China | Jiangxi Chest (Third People) Hospital | Nanchang | |
China | Shanghai Pulmonary Hospital | Shanghai | |
China | Hebei Chest Hospital | Shijiangzhuang | |
China | The Fifth People Hospital of Suzhou | Suzhou | |
China | The Fourth People's Hospital of Taiyuan | Taiyuan | |
China | Wuhan Institute For Tuberculosis Control | Wuhan | |
China | Wuhan Jinyintan Hospital | Wuhan | |
China | Xi'an Chest Hospital | Xi'an | |
China | Shanxi Provincial Tuberculosis Institute | Xian | |
China | Henan Provincial Chest Hospital | Zhengzhou |
Lead Sponsor | Collaborator |
---|---|
Beijing Chest Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of participants experiencing all-cause mortality | the percentage of participants who died during the trial. | from enrollment to the completion of the trial ,an average of 30-32months | |
Primary | Proportion of participants experiencing treatment-emergent AEs | the percentage of participants who experienced adverse effect during treatment phase. | the whole treatment phase,an average of 18-20 months | |
Secondary | The Percentage of Participants With Sputum Culture Conversion | Sputum culture conversion is defined as 2 consecutive sputum cultures negative for multidrug-resistant tuberculosis (MDR-TB) taken at least 25 days apart. | up to 24 weeks after enrollment | |
Secondary | The Median Time to Sputum Culture Conversion | Sputum culture conversion is defined as 2 consecutive sputum cultures negative for multidrug-resistant tuberculosis (MDR-TB) taken at least 25 days apart. | upto 24 weeks after enrollment |
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