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)

NCT06674291 | Not Yet Recruiting

• 1 other identifier: 242-402-00031
• Study Type: observational
• Target: 222
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Tuberculosis, Multidrug-Resistant

Outcome Measures

Primary Outcomes (1)

• 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.

  At the end of treatment

Secondary Outcomes (6)

• Treatment success rate at 12 months after the end of treatment (end of study)

  At 12 months after the end of treatment (end of study)

• Recurrence rate after treatment success

  During follow up period (12 months after the end of treatment)

• Treatment-emergent adverse events (TEAEs)

  During the treatment period and up to one month after the end of treatment

• TEAEs by severity

  During the treatment period and up to one month after the end of treatment

• Mortality and time to death

  During the treatment period and up to one month after the end of treatment

Study Arms (1)

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).

Drug: No intervention (observational study)

Interventions

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.

MDR-END regimen treatment group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Korea Otsuka Pharmaceutical Co., Ltd.: lead

MeSH Terms

Conditions

Tuberculosis, Multidrug-Resistant

Interventions

Observation

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Central Study Contacts

Minyi Lee

CONTACT

+82-02-3287-9286; minyi.lee@kr.otsuka.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2024
• First Posted: November 5, 2024
• Study Start: November 30, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: November 5, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share