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NCT Number: 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)

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.

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Key information

Conditions

Tuberculosis, Multidrug-Resistant Actinomycetales Infections Bacterial Infections Bacterial Infections and Mycoses Gram-Positive Bacterial Infections Infections Mycobacterium Infections Tuberculosis

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

  2. Recurrence rate after treatment success

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

  3. Treatment-emergent adverse events (TEAEs)

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

  4. TEAEs by severity

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

  5. Mortality and time to death

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

  6. TEAEs related to QT prolongation

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

Study contacts

Contact information is provided by the study sponsor or research team.

Minyi Lee

CONTACT

[email protected]

+82-02-3287-9286

Sponsors and collaborators

Lead sponsor

Korea Otsuka Pharmaceutical Co., Ltd.

Industry

Registry information

Official study 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)

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Nov 5, 2024
Registry last updated
Nov 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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