Safety and Effectiveness of Delamanid-containing Regimen for MDR-TB Patients in China
1 other identifier
interventional
608
1 country
25
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Jul 2020
Longer than P75 for phase_4
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 1, 2020
CompletedFirst Posted
Study publicly available on registry
June 9, 2020
CompletedStudy Start
First participant enrolled
July 16, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 16, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 16, 2024
CompletedJuly 7, 2022
July 1, 2022
1.9 years
June 1, 2020
July 5, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (2)
The Percentage of Participants With Sputum Culture Conversion
up to 24 weeks after enrollment
The Median Time to Sputum Culture Conversion
upto 24 weeks after enrollment
Study Arms (1)
delamanid containing regimen arm
EXPERIMENTALthe only one arm to be studied with delamid-containing regimen.
Interventions
the eligible patients will be give damanid-containing regimen
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
- +10 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (25)
Beijing Chest Hospital, Capital Medical University
Beijing, 101149, 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
Liuchow, 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
Shanxi Provincial Tuberculosis Institute
Xi'an, China
Xi'an Chest Hospital
Xi'an, China
Henan Provincial Chest Hospital
Zhengzhou, China
Related Publications (2)
Qin Y, Chen Y, Cai Q. Interim efficacy and safety analysis of the regimen containing delamanid in the treatment of multidrug resistant/rifampicin-resistant/extensively drug-resistant tuberculosis: a single-arm, prospective, monocentric, observational study. BMC Infect Dis. 2025 Dec 19. doi: 10.1186/s12879-025-11945-9. Online ahead of print.
PMID: 41419836DERIVEDYang F, Yin M, Jiang X, Zhao X, An X, Liu Y, Yuan Y. Delamanid-containing regimens over 24 weeks for the treatment of multidrug-resistant/rifampicin-resistant tuberculosis: preliminary results from a single center in a multicenter, prospective, observational study. Front Med (Lausanne). 2025 Sep 29;12:1631030. doi: 10.3389/fmed.2025.1631030. eCollection 2025.
PMID: 41090140DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Liang Li
Beijing Chest Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Vice president
Study Record Dates
First Submitted
June 1, 2020
First Posted
June 9, 2020
Study Start
July 16, 2020
Primary Completion
June 16, 2022
Study Completion
July 16, 2024
Last Updated
July 7, 2022
Record last verified: 2022-07