BPaL Regimen in FQ resistant MDR-TB

Not Applicable

• Conditions: Certain infectious and parasitic diseases

• Registration Number: KCT0007234
• Lead Sponsor: Asan Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 2 May 2022

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1) At least 19 years old at enrollment
2) Bodyweight over 35Kg
3) If culture positive in sputum or bronchoscopy specimen within 3 months of screening and confirmed as MDR-TB in the rapid or conventional DST.
4) Confirmed as resistance to fluoroquinolones in rapid and/or genotypic DST
5) If tuberculosis is confirmed by chest radiologic imaging

Exclusion Criteria

1) Uncontrolled DM
2) Extrapulmonary TB that would require treatment longer than would be usual for pulmonary TB
3) Less than 30 Karnofsky score at enrolment
4) BMI less than 17
5) Known severe allergy to any of the BPaL component drugs
6) Medical history of Glucose-galactose malabsorption, galactose intolerance and Lapp lactase deficiency
7) HIV-positive
8) When QTcF interval exceeds 500 msec on the electrocardiogram at baseline
9) Patients who are at risk of Torsade de Pointes due to underlying heart disease such as heart failure or arrhythmia
10) For women of childbearing potential, if the pregnancy test is positive, women who are breastfeeding or planning to become pregnant within 6 months of discontinuation/termination of treatment during the study, or who do not want contraception (i.e., oral and subcutaneous hormonal contraceptives, condoms, diaphragms, intrauterine device, or use of appropriate contraceptive methods including abstinence)
11) Men who plan to become pregnant during the study period or within 6 months of discontinuation/termination of treatment, or who do not wish to use double contraception or abstinence during this period.
12) Patients who have Grade 3 or 4 or higher peripheral neuritis, or Grade 1 or 2 with a high probability of progression to peripheral neuritis,
13) Current use of monoamine oxidase Inhibitor or used 2 weeks before treatment
14) Use of serotonergic antidepressant within 3 days of treatment
15) Any contraindication that may affect QTc interval (amiodarone, chloroquine, chlorpromazine, clarithromycin, haloperidol, etc.)
16) Any contraindication that may cause myelosuppression
17) Taking drugs that affect the cytochrome P450 enzyme within 30 days (quinidine,tyramine, ketoconazole, fluconazole, testosterone, quinine, gestodene, metyrapone,phenelzine, doxorubicin, troleandomycin, cyclobenzaprine, erythromycin, cocaine,furafylline, cimetidine, dextromethorphan etc.)
18) Previously treated with Bedaquiline or Linezolid for more than 4 weeks
19) Abnormal value of a blood test at baseline:
- Hypokalemia
- Hemoglobin < 8.0 g/dL
- Platelet < 75,000/mm3
- Absolute Neutrophil Count (ANC) < 1000/mm3
- AST or ALT > 3.0 X upper limit of normal (ULN)
- Total bilirubin >2.0 X upper limit of normal (ULN)
- Albumin < 3.2 mg/dL
- Serum creatinine > 2.0 X upper limit of normal (ULN)
- Serum calcium < lower limit of normal (LLN)
- Serum magnesium < lower limit of normal (LLN)

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
microbiological failure or clinical failure or relapse

Secondary Outcome Measures

Name	Time	Method
Time to culture conversion;The proportion of patients who achieved culture conversion at the specific time point;The dosage of linezolid;All cause mortality;The rate of total adverse event, the rate of adverse events leading to drug discontinuation