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)

Otsuka

Status: Not yet enrolling

Conditions: Tuberculosis, Multidrug-Resistant

Treatments: Drug: No intervention (observational study)

Study type: Observational

Funder types: Industry

Identifiers

NCT06674291

242-402-00031

Details and patient eligibility

About

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.

Enrollment: 222 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

222 participants in 1 patient group

MDR-END regimen treatment group

Description:

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).

Treatment:

Drug: No intervention (observational study)