Status:
ACTIVE_NOT_RECRUITING
Study to Evaluate the Efficacy of Delpazolid as Add-on Therapy in Refractory Mycobacterium Abscessus Complex
Lead Sponsor:
LigaChem Biosciences, Inc.
Conditions:
Nontuberculous Mycobacterium Infection
Mycobacterium Abscessus Infection
Eligibility:
All Genders
19+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of delpazolid add-on therapy in Patients with Refractory Mycobacterium abscessus Complex Pulmonary disease
Detailed Description
Delpazolid, which demonstrates effects similar to other oxazolidinone-class drugs and has confirmed good safety, aims to evaluate its efficacy in MABC-PD patients who are unresponsive to guideline-bas...
Eligibility Criteria
Inclusion
- Pre-screening: Adults aged 19 years or above
- Pre-screening: Patients diagnosed with MABC (including subspecies abscessus, bolletii, and massiliense) pulmonary disease in radiologic and microbiologic evaluations
- LCB01-0371 MIC ≤ 8 μg/mL for MABC
- Patients who continue to show positivity for MABC even after treatments based on the guidelines of ATS/ERS/ESCMID/IDSA for at least 6 months prior to screening, and who meet all of the following criteria:
- Patients who have been confirmed positive at least once in the last sputum or bronchoscopy sample culture performed prior to screening
- Patients who have not achieved culture conversion (at least 3 consecutive negative mycobacteria cultures in the sputum or bronchoscopy sample collected at an interval of at least 4 weeks) within 6 months prior to screening
- Patients who can voluntarily expectorate sputum at screening
- Patients with a life expectancy of 12 weeks or more
- Patients with adequate organ function who meet the following criteria:
- Hemoglobin \> 9.0 g/dL (without transfusion within 2 weeks prior to measurement)
- Absolute neutrophil count ≥ 1,500/µL (without administration of G-CSF within 2 weeks prior to measurement)
- Platelet ≥ 100,000/µL
- Total bilirubin ≤ 1.5 × upper limit of normal (ULN)
- Alanine aminotransferase/aspartate aminotransferase (ALT/AST) ≤ 2.5 × ULN
- Serum creatinine ≤ 1.5 × ULN or creatinine clearance \>30 mL/min (calculated with the Cockcroft-Gault formula)
- Patients who voluntarily provided a written consent to participate in the clinical study
Exclusion
- Patients who cannot swallow the study drug tablet due to dysphagia, nasogastric tube insertion, etc.
- Patients diagnosed with cystic fibrosis
- Patients who have received a lung transplant
- Patients with disseminated or extrapulmonary nontuberculous mycobacteria
- Patients with known active pulmonary tuberculosis
- Patients with NTM infections other than MABC
- Patients with an active pulmonary malignancy within 1 year prior to screening or Patients with other malignancies that require chemotherapy or radiotherapy
- Patients who has received linezolid for MABC treatment within 3 months prior to screening
- Patients with known HIV positivity or a suspected infection thereof or Patients with a known active hepatitis B or C infection
- Patients who currently have a clinically significant cardiovascular disease
- Patients with severe cardiac failure (New York Heart Association \[NYHA\] class III/IV) that occurred within 24 weeks prior to screening
- Patients with pulmonary embolism or deep venous thrombosis that occurred within 24 weeks prior to screening
- Patients whose multidrug therapy for treatment of MABC was changed within 4 weeks prior to screening (Discontinuation, dose adjustment, change of administration route, etc., are allowed.)
- Patients for whom the administration of contraindicated concomitant drugs that correspond to the following cannot be discontinued during the clinical study or for whom their administration is necessary
- Administration of a new antibacterial agent for the prioritized treatment of NTM, especially MABC, other than background therapy
- Monoamine oxidase inhibitors
- Serotonin reuptake inhibitor or serotonin 5-HT1 receptor agonists
- Meperidine or buspirone
- Drugs that lower epilepsy threshold; tramadol, etc.
- Tricyclic Antidepressant
- Other investigational products: If there is a history of administration within 30 days prior to screening, it falls under the exclusion criteria.
- Pregnant or breastfeeding women and women of childbearing potential who do not agree to practice appropriate contraceptive methods\*:
Key Trial Info
Start Date :
January 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06004037
Start Date
January 16 2024
End Date
December 30 2026
Last Update
August 22 2025
Active Locations (5)
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1
Asan Medical Center
Seoul, South Korea
2
Bundang Seoul National University Hospital
Seoul, South Korea
3
Samsung Medical Center
Seoul, South Korea
4
Seoul National University Bundang Hospital
Seoul, South Korea