Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2025-12-24 @ 2:14 PM
NCT ID:
NCT04421495
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04421495
Study Brief:
Protocol Section:
NCT04421495