Clinical trial NCT06674291: 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)
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)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Tuberculosis, Multidrug-Resistant
Lead sponsor: Korea Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-11-05
Enrollment: 222
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.


Eligibility criteria: Inclusion Criteria:

1. Adults aged 19 years or older who have been diagnosed with multidrug resistant pulmonary tuberculosis
2. 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

Exclusion Criteria:

1. Patients with confirmed quinolone resistance
2. Patients with hypersensitivity to one or more of the following drugs: Delamanid, Linezolid, Levofloxacin, and Pyrazinamide
3. Patients who are found to have contraindications according to the approved labels of Delamanid, Linezolid, Levofloxacin, or Pyrazinamide
4. Patients with or with a history of optic neuritis or peripheral neuritis
5. Patients with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
6. Pregnant or lactating women
7. Women of childbearing potential who are unwilling to use appropriate contraception during the study treatment

Primary outcomes:
measure: Treatment success rate at the end of treatment
timeFrame: At the end of treatment
Secondary outcomes:
measure: Treatment success rate at 12 months after the end of treatment (end of study)
timeFrame: At 12 months after the end of treatment (end of study)
measure: Recurrence rate after treatment success
timeFrame: During follow up period (12 months after the end of treatment)
measure: Treatment-emergent adverse events (TEAEs)
timeFrame: During the treatment period and up to one month after the end of treatment
measure: TEAEs by severity
timeFrame: During the treatment period and up to one month after the end of treatment
measure: Mortality and time to death
timeFrame: During the treatment period and up to one month after the end of treatment
measure: TEAEs related to QT prolongation
timeFrame: During the treatment period and up to one month after the end of treatment
Other outcomes:
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