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Multidrug Resistant TuberculosisPhase 4NCT04421495

Safety and Effectiveness of Delamanid-containing Regimen for MDR-TB Patients in China

A Phase 4 study testing Delamanid in people with Multidrug Resistant Tuberculosis, run by Beijing Chest Hospital at 25 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Multidrug Resistant Tuberculosis
What is being tested?
Delamanid
Could I receive a placebo?
No, everyone receives an active treatment
How many people
608 participants
Where
25 sitesChina
Study dates
16 Jul 2020to 16 Jul 2024
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

25 sites in 1 country.

25 sites in 1 country

China25 sites

  • Beijing Chest Hospital, Capital Medical University

    Beijing, 101149

  • Changsha Central Hospital

    Changsha

  • Public Health Clinical Center of Chengdu

    Chengdu

  • Chongqing Infectious Disease Medical Center

    Chongqing

  • Fuzhou Pulmonary Hospital of Fujian

    Fuzhou

  • Guangzhou Chest Hospital

    Guangzhou

  • Guiyang Public Health Clinical Center

    Guiyang

  • Heilongjiang Province center for tuberculosis Control and Prevention

    Haerbin

  • Hangzhou Red Cross Hospital

    Hangzhou

  • Jiamusi Tumor Hospital

    Jiamusi

  • Tuberculosis Hospital in Jilin Province

    Jilin City

  • Shandong Provincial Chest Hospital

    Jinan

  • The Third People's Hospital of Kunming City

    Kunming

  • Lanzhou Pulmonary Hospital

    Lanzhou

  • Longtan Hospital of Guangxi Zhuang Autonomous Region

    Liuzhou

  • Jiangxi Chest (Third People) Hospital

    Nanchang

  • Shanghai Pulmonary Hospital

    Shanghai

  • Hebei Chest Hospital

    Shijiangzhuang

  • The Fifth People Hospital of Suzhou

    Suzhou

  • The Fourth People's Hospital of Taiyuan

    Taiyuan

  • Wuhan Institute For Tuberculosis Control

    Wuhan

  • Wuhan Jinyintan Hospital

    Wuhan

  • Shanxi Provincial Tuberculosis Institute

    Xi'an

  • Xi'an Chest Hospital

    Xi'an

  • Henan Provincial Chest Hospital

    Zhengzhou

Other trials in China

About this study

Official title: Safety and Effectiveness of Delamanid-containing Regimen for Treatment of Patients With Multidrug-resistant Tuberculosis in China

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.

Read the 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 confirmed pulmonary MDR-TB in China. A target of 600 participants will be enrolled. The study will consist of a screening phase of up to 8 weeks, an open-label study treatment phase of 13-20 months, and a follow-up phase of 12-month after end of study treatment. During the study treatment phase, participants will receive an MDR-TB regimen consisting of 24 weeks of delamanid in combination with 13-20 months of a background regimen.

Participants will be instructed to take their assigned dose of delamanid with at least 3 additional probably effective background drugs according to national and international guidelines. Delamanid dosage will be 100 mg twice daily (b.i.d.) for 24 weeks.

Safety evaluations will include monitoring of AEs, visual acuity testing, routine blood examinations (such as hematology, clinical chemistry, HIV, TSH [for subjects receiving PTO] measurements), urinalysis, and electrocardiograms (ECGs). Participants will initiate treatment with the study regimen if they meet the study eligibility criteria.The end of study will be considered as the last contact for the last participant in the study.

A participant will be considered to have completed the study if he or she has completed the 13-20 months study treatment phase and the required post-treatment follow-up phase. Participants who prematurely discontinue study treatment (unless they withdraw consent) will be followed up for 12 months after end of delamanid treatment.

Being tested
Delamanid
Keywords
safety, Delamanid, effectiveness
Medical subject headings
Tuberculosis, Multidrug-Resistant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DelamanidDrug

    Also called anti-TB new drug containing regimen

    the eligible patients will be give damanid-containing regimen

Study groups in NCT04421495
Study groupRoleWhat they receive
delamanid containing regimen armExperimentalthe only one arm to be studied with delamid-containing regimen.
Receives: Drug: Delamanid

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of participants experiencing all-cause mortality

    the percentage of participants who died during the trial.

    Measured: from enrollment to the completion of the trial ,an average of 30-32months

  2. Proportion of participants experiencing treatment-emergent AEs

    the percentage of participants who experienced adverse effect during treatment phase.

    Measured: the whole treatment phase,an average of 18-20 months

Secondary outcomes (2)

  1. 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.

    Measured: up to 24 weeks after enrollment

  2. 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.

    Measured: upto 24 weeks after enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2020
  2. Study start16 Jul 2020
  3. Primary completion16 Jun 2022
  4. Study completion16 Jul 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
608 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04421495
Sponsor's protocol ID
LCSY-TB-2020-002
Status last verified
Jul 2022
First submitted
1 Jun 2020
Last updated
7 Jul 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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;26(1):124. doi: 10.1186/s12879-025-11945-9.

    PubMed 41419836

  • Yang 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.

    PubMed 41090140

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Delamanid in people with Multidrug Resistant Tuberculosis, run by Beijing Chest Hospital at 25 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 25 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants experiencing all-cause mortality (time frame: from enrollment to the completion of the trial ,an average of 30-32months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04421495, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2022.

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