Status:
UNKNOWN
Safety and Effectiveness of Delamanid-containing Regimen for MDR-TB Patients in China
Lead Sponsor:
Beijing Chest Hospital
Conditions:
Multidrug Resistant Tuberculosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
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.
Detailed Description
This is a single-arm, multicenter, phase #, open-label trial to evaluate the safety and effectiveness of delamanid-containing regimen in men and women aged 18 to 65 years with microbiologically confir...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 16 2024
Estimated Enrollment :
608 Patients enrolled
Trial Details
Trial ID
NCT04421495
Start Date
July 16 2020
End Date
July 16 2024
Last Update
July 7 2022
Active Locations (25)
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1
Beijing Chest Hospital, Capital Medical University
Beijing, China, 101149
2
Changsha Central Hospital
Changsha, China
3
Public Health Clinical Center of Chengdu
Chengdu, China
4
Chongqing Infectious Disease Medical Center
Chongqing, China