Tuberculosis, Multidrug-ResistantNCT06674291
Registry on the Effectiveness and Safety of the 9-month MDR-END Treatment Regimen in Korean Patients with FQ-sensitive MDR-TB (MDR-END Registry)
An observational study of Tuberculosis, Multidrug-Resistant, run by Korea Otsuka Pharmaceutical Co., Ltd..
Trial summary
This study is to evaluate the effectiveness and safety of a 9-month MDR-END regimen as a treatment for fluoroquinolone-sensitive multidrug resistant pulmonary tuberculosis in the real-world clinical setting. It will be conducted as a non-interventional, prospective, single group, multicenter design. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Tuberculosis, Multidrug-Resistant
- How many people
- 222 participants
- Where
- No sites listed yet
- Study dates
- 30 Nov 2024to 31 Dec 2028
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 222 adult men and women with fluoroquinolone-sensitive multidrug resistant pulmonary tuberculosis will be enrolled in this study. To determine the sample size of this study, the treatment success rate of the study group in the MDR-END trial treated with Delamanid, Linezolid, Levofloxacin, and Pyrazinamide to shorten the treatment duration of multidrug resistant tuberculosis in patients with fluoroquinolone-sensitive multidrug resistant tuberculosis was assumed to be the expected effectiveness rate. The treatment success rate of the study group in the MDR-END trial was 84.72% according to the 5th edition of the Korean Guidelines for Tuberculosis, and the number of subjects required was 222 subjects calculated with a 95% confidence interval, 5% tolerance and 10% dropout rate.
Who may be able to join
- Adults aged 19 years or older who have been diagnosed with multidrug resistant pulmonary tuberculosis
- Adults prescribed MDR-END regimen according to the Korean Guidelines for Tuberculosis after being informed of this study from the investigator and signing an informed consent form
Who cannot join
- Patients with confirmed quinolone resistance
- Patients with hypersensitivity to one or more of the following drugs: Delamanid, Linezolid, Levofloxacin, and Pyrazinamide
- Patients who are found to have contraindications according to the approved labels of Delamanid, Linezolid, Levofloxacin, or Pyrazinamide
- Patients with or with a history of optic neuritis or peripheral neuritis
- Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
- Pregnant or lactating women
- Women of childbearing potential who are unwilling to use appropriate contraception during the study treatment
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Registry on the Effectiveness and Safety of the 9-month MDR-END Treatment Regimen (Delamanid, Linezolid, Levofloxacin, Pyrazinamide) in Korean Patients with Fluoroquinolone-Sensitive Pulmonary Multi-Drug Resistant Tuberculosis (MDR-TB) : a Non-interventional, Prospective Observational Study (MDR-END Registry)
This study is to evaluate the effectiveness and safety of a 9-month MDR-END regimen as a treatment for fluoroquinolone-sensitive multidrug resistant pulmonary tuberculosis in the real-world clinical setting.
It will be conducted as a non-interventional, prospective, single group, multicenter design.
Subjects who are considered to meet the inclusion /exclusion criteria will receive MDR-END regimen for 9 months (or 12 months) during the treatment period according to the 5th edition of the Korean Guidelines for Tuberculosis, and will be followed-up for 12 months after the end of treatment.
- Conditions
- Tuberculosis, Multidrug-Resistant
- Being tested
- No intervention (observational study)
- 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.
No intervention (observational study)Drug
This is an observational registry conducted in the real world clinical setting and there is no intervention in this study. Treatment of MDR-END Regimen and the follow-up of subjects will be conducted in the clinical judgment of the investigator.
| Study group | Role | What they receive |
|---|---|---|
| MDR-END regimen treatment group | 1. Treatment Regimen
Delamanid 100 mg twice daily Linezolid 600 mg once daily for the first 2 months, 300 mg once daily afterward Levofloxacin (body weight ≤ 50 kg) 750 mg once daily (body weight > 50 kg) 1000 mg once daily Pyrazinamide (body weight < 50 kg) 1000 mg once daily (body weight 50 to 70 kg) 1500 mg once daily (body weight > 70 kg) 2000 mg once daily
2. Treatment period : 9 month (40 weeks) If the sputum test results show conversion within 3-6 months after the start of treatment, the overall treatment period is extended by 3 months for a total of 12 months (52 weeks). Receives: Drug: No intervention (observational study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment success rate at the end of treatment
"Cured" and "Treatment Completed" from the result of multidrug resistant pulmonary tuberculosis treatment are defined as treatment success, and the treatment outcomes of multidrug resistant pulmonary tuberculosis treatment are determined according to the 5th edition of the Korean Guidelines for Tuberculosis.
Measured: At the end of treatment
Secondary outcomes (6)
Treatment success rate at 12 months after the end of treatment (end of study)
Measured: At 12 months after the end of treatment (end of study)
Recurrence rate after treatment success
Measured: During follow up period (12 months after the end of treatment)
Treatment-emergent adverse events (TEAEs)
Measured: During the treatment period and up to one month after the end of treatment
TEAEs by severity
Measured: During the treatment period and up to one month after the end of treatment
Mortality and time to death
Measured: During the treatment period and up to one month after the end of treatment
TEAEs related to QT prolongation
Measured: During the treatment period and up to one month after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2024
- Study start30 Nov 2024 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tuberculosis, Multidrug-ResistantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 222 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06674291
- Sponsor's protocol ID
- 242-402-00031
- Status last verified
- Oct 2024
- First submitted
- 3 Nov 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry on the Effectiveness and Safety of the 9-month MDR-END Treatment Regimen (Delamanid, Linezolid, Levofloxacin, Pyrazinamide) in Korean Patients with Fluoroquinolone-Sensitive Pulmonary Multi-Drug Resistant Tuberculosis (MDR-TB) : a Non-interventional, Prospective Observational Study (MDR-END Registry)
- ClinicalTrials.gov ID
- NCT06674291
- Acronym / sponsor ID
- 242-402-00031
- Conditions
- Tuberculosis, Multidrug-Resistant
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 222 participants (estimated)
- Lead sponsor
- Korea Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Nov 2024 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 5 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to evaluate the effectiveness and safety of a 9-month MDR-END regimen as a treatment for fluoroquinolone-sensitive multidrug resistant pulmonary tuberculosis in the real-world clinical setting.
It will be conducted as a non-interventional, prospective, single group, multicenter design.
Subjects who are considered to meet the inclusion /exclusion criteria will receive MDR-END regimen for 9 months (or 12 months) during the treatment period according to the 5th edition of the Korean Guidelines for Tuberculosis, and will be followed-up for 12 months after the end of treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MDR-END regimen treatment group | – | Drug: No intervention (observational study)1. Treatment Regimen Delamanid 100 mg twice daily Linezolid 600 mg once daily for the first 2 months, 300 mg once daily afterward Levofloxacin (body weight ≤ 50 kg) 750 mg once daily (body weight > 50 kg) 1000 mg once daily Pyrazinamide (body weight < 50 kg) 1000 mg once daily (body weight 50 to 70 kg) 1500 mg once daily (body weight > 70 kg) 2000 mg once daily 2. Treatment period : 9 month (40 weeks) If the sputum test results show conversion within 3-6 months after the start of treatment, the overall treatment period is extended by 3 months for a total of 12 months (52 weeks). |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 222 adult men and women with fluoroquinolone-sensitive multidrug resistant pulmonary tuberculosis will be enrolled in this study. To determine the sample size of this study, the treatment success rate of the study group in the MDR-END trial treated with Delamanid, Linezolid, Levofloxacin, and Pyrazinamide to shorten the treatment duration of multidrug resistant tuberculosis in patients with fluoroquinolone-sensitive multidrug resistant tuberculosis was assumed to be the expected effectiveness rate. The treatment success rate of the study group in the MDR-END trial was 84.72% according to the 5th edition of the Korean Guidelines for Tuberculosis, and the number of subjects required was 222 subjects calculated with a 95% confidence interval, 5% tolerance and 10% dropout rate.
Key inclusion criteria (2 listed)
- Adults aged 19 years or older who have been diagnosed with multidrug resistant pulmonary tuberculosis
- Adults prescribed MDR-END regimen according to the Korean Guidelines for Tuberculosis after being informed of this study from the investigator and signing an informed consent form
Key exclusion criteria (7 listed)
- Patients with confirmed quinolone resistance
- Patients with hypersensitivity to one or more of the following drugs: Delamanid, Linezolid, Levofloxacin, and Pyrazinamide
- Patients who are found to have contraindications according to the approved labels of Delamanid, Linezolid, Levofloxacin, or Pyrazinamide
- Patients with or with a history of optic neuritis or peripheral neuritis
- Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention (observational study)This is an observational registry conducted in the real world clinical setting and there is no intervention in this study. Treatment of MDR-END Regimen and the follow-up of subjects will be conducted in the clinical judgment of the investigator. | Drug | MDR-END regimen treatment group |
Primary outcome
Treatment success rate at the end of treatment
Time frame: At the end of treatment
"Cured" and "Treatment Completed" from the result of multidrug resistant pulmonary tuberculosis treatment are defined as treatment success, and the treatment outcomes of multidrug resistant pulmonary tuberculosis treatment are determined according to the 5th edition of the Korean Guidelines for Tuberculosis.
6 secondary outcomes
Treatment success rate at 12 months after the end of treatment (end of study)
Time frame: At 12 months after the end of treatment (end of study)
Recurrence rate after treatment success
Time frame: During follow up period (12 months after the end of treatment)
Treatment-emergent adverse events (TEAEs)
Time frame: During the treatment period and up to one month after the end of treatment
TEAEs by severity
Time frame: During the treatment period and up to one month after the end of treatment
Mortality and time to death
Time frame: During the treatment period and up to one month after the end of treatment
TEAEs related to QT prolongation
Time frame: During the treatment period and up to one month after the end of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis, Multidrug-Resistant, run by Korea Otsuka Pharmaceutical Co., Ltd..
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 2 inclusion and 7 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: opening soon, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Minyi Lee (+82-02-3287-9286, minyi.lee@kr.otsuka.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment success rate at the end of treatment (time frame: At the end of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Nov 2024.