Study to Evaluate the Efficacy of Delpazolid as Add-on Therapy in Refractory Mycobacterium Abscessus Complex
- Conditions
- Nontuberculous Mycobacterium InfectionMycobacterium Abscessus Infection
- Registration Number
- NCT06004037
- Lead Sponsor
- LigaChem Biosciences, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br> - Pre-screening: Adults aged 19 years or above<br><br> - Pre-screening: Patients diagnosed with MABC (including subspecies abscessus,<br> bolletii, and massiliense) pulmonary disease in radiologic and microbiologic<br> evaluations<br><br> - LCB01-0371 MIC = 4 µg/mL for MABC<br><br> - Patients who continue to show positivity for MABC even after treatments based on the<br> guidelines of ATS/ERS/ESCMID/IDSA for at least 6 months prior to screening, and who<br> meet all of the following criteria:<br><br> 1. Patients who have been confirmed positive at least once in the last sputum or<br> bronchoscopy sample culture performed prior to screening<br><br> 2. Patients who have not achieved culture conversion (at least 3 consecutive<br> negative mycobacteria cultures in the sputum or bronchoscopy sample collected<br> at an interval of at least 4 weeks) within 6 months prior to screening<br><br> - Patients who can voluntarily expectorate sputum at screening<br><br> - Patients with a life expectancy of 12 weeks or more<br><br> - Patients with adequate organ function who meet the following criteria:<br><br> 1. Hemoglobin > 9.0 g/dL (without transfusion within 2 weeks prior to measurement)<br><br> 2. Absolute neutrophil count = 1,500/µL (without administration of G-CSF within 2<br> weeks prior to measurement)<br><br> 3. Platelet = 100,000/µL<br><br> 4. Total bilirubin = 1.5 × upper limit of normal (ULN)<br><br> 5. Alanine aminotransferase/aspartate aminotransferase (ALT/AST) = 2.5 × ULN<br><br> 6. Serum creatinine = 1.5 × ULN or creatinine clearance >30 mL/min (calculated<br> with the Cockcroft-Gault formula)<br><br> - Patients who voluntarily provided a written consent to participate in the clinical<br> study<br><br>Exclusion Criteria:<br><br> - Patients who cannot swallow the study drug tablet due to dysphagia, nasogastric tube<br> insertion, etc.<br><br> - Patients diagnosed with cystic fibrosis<br><br> - Patients who have received a lung transplant<br><br> - Patients with disseminated or extrapulmonary nontuberculous mycobacteria<br><br> - Patients with known active pulmonary tuberculosis<br><br> - Patients with NTM infections other than MABC<br><br> - Patients with an active pulmonary malignancy within 1 year prior to screening or<br> Patients with other malignancies that require chemotherapy or radiotherapy<br><br> - Patients who were administered linezolid for more than 2 weeks to treat MABC<br><br> - Patients with known HIV positivity or a suspected infection thereof or Patients with<br> a known active hepatitis B or C infection<br><br> - Patients who currently have a clinically significant cardiovascular disease<br><br> 1. Patients with severe cardiac failure (New York Heart Association [NYHA] class<br> III/IV) that occurred within 24 weeks prior to screening<br><br> 2. Patients with pulmonary embolism or deep venous thrombosis that occurred within<br> 24 weeks prior to screening<br><br> - Patients whose multidrug therapy for treatment of MABC was changed within 4 weeks<br> prior to screening (Discontinuation, dose adjustment, change of administration<br> route, etc., are allowed.)<br><br> - Patients for whom the administration of contraindicated concomitant drugs that<br> correspond to the following cannot be discontinued during the clinical study or for<br> whom their administration is necessary<br><br> 1. Administration of a new antibacterial agent for the prioritized treatment of<br> NTM, especially MABC, other than background therapy<br><br> 2. Monoamine oxidase inhibitors<br><br> 3. Serotonin reuptake inhibitor or serotonin 5-HT1 receptor agonists<br><br> 4. Meperidine or buspirone<br><br> 5. Drugs that lower epilepsy threshold; tramadol, etc.<br><br> 6. Other investigational products: If there is a history of administration within<br> 30 days prior to screening, it falls under the exclusion criteria.<br><br> - Pregnant or breastfeeding women and women of childbearing potential who do not agree<br> to practice appropriate contraceptive methods*:
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline in the semi-quantitative scale (SQS)
- Secondary Outcome Measures
Name Time Method Change from baseline in SQS;Sputum culture conversion rate;Time to culture conversion;Time to positivity in the liquid culture automated system (MGIT);Negative sputum culture rate at each time point after baseline;Change from baseline in the inflammatory marker;Change from baseline in the CT score;Quality of Life Questionnaire-Bronchiectasis;Six-minute walk test