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)

Launched by KOREA OTSUKA PHARMACEUTICAL CO., LTD. · Nov 3, 2024

Keywords

ClinConnect Summary

The MDR-END Registry is a clinical trial that aims to learn more about how effective and safe a 9-month treatment called the MDR-END regimen is for patients with a specific type of tuberculosis (TB) known as multidrug-resistant pulmonary tuberculosis, which is sensitive to a class of antibiotics called fluoroquinolones. This study will take place in several hospitals and will involve adults aged 19 and older who have been diagnosed with this type of TB and are eligible to receive the MDR-END treatment according to Korean guidelines.

If you or a loved one qualify for this study, you will receive the MDR-END regimen for either 9 or 12 months, depending on your specific situation, and you will be monitored for 12 months after completing the treatment. It's important to note that some individuals will not be eligible to participate, such as those with certain drug resistances, allergies to specific medications, or specific health issues. Participation in this study requires informed consent, meaning you will be fully informed about the trial and its requirements before agreeing to take part.

Gender

ALL

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