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
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-based treatments
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Three tablets (400 mg/tablet) of delpazolid will be orally administered once daily for 12 weeks. After 3 months (12 weeks) of administration, if the investigator determines that there are clinical benefits, an additional extended treatment of up to 9 months (40 weeks) may be given, amounting to 1 year of treatment in total.
Asan Medical Center
Seoul, South Korea
Bundang Seoul National University Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Seoul National University Bundang Hospital
Seoul, South Korea
semi-quantitative scale (SQS) change versus baseline
The SQS using liquid media and solid media will be scored a point of 1-7, with lower scores representing a reducing bacterial load.
Time frame: 12 weeks
Change from baseline in SQS
The SQS using liquid media and solid media will be scored a point of 1-7, with lower scores representing a reducing bacterial load.
Time frame: 4 weeks and 8 weeks
Sputum culture conversion rate
neg culture x3( sputum conversion)
Time frame: 12 weeks
Time to culture conversion
from the date of assignment to the first negative result.
Time frame: 12 weeks
Time to positivity in the liquid culture automated system (MGIT)
time to detection of positive in MGIT system
Time frame: 12 weeks
Negative sputum culture rate at each time point after baseline
negative culture results in MGIT and solid media
Time frame: 12 weeks
Change from baseline in the inflammatory marker
erythrocyte sedimentation rate \[ESR\]) at each time point
Time frame: 12 weeks
Change from baseline in the CT score
The CT scan score will be transformed onto a scale of 0-42, with lower scores representing improved lung presentations. Descriptive statistics for each point in time are presented, and intra-group comparison of CT score changes at 12 weeks compared to baseline
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Severance Hospital
Seoul, South Korea
Time frame: 12 weeks
Quality of Life Questionnaire-Bronchiectasis
The QOL-B respiratory symptoms score was transformed onto a scale of 0-100, with higher scores representing a better quality of life.
Time frame: 12 weeks
Six-minute walk test
Six-minute walk test
Time frame: 12 weeks
Extended administration
1\) SQS at each time point compared to baseline in subjects receiving extended administration * The SQS using liquid media and solid media will be scored a point of 1-7, with lower scores representing a reducing bacterial load 2) Inflammatory markers at each time point compared to baseline in subjects receiving extended administration * erythrocyte sedimentation rate 3) CT scores at each time point compared to baseline in subjects receiving extended administration * The CT scan score will be transformed onto a scale of 0-42, with lower scores representing improved lung presentations. 4\) QOL-B change at each time point compared to baseline in subjects receiving extended administration * The QOL-B respiratory symptoms score was transformed onto a scale of 0-100, with higher scores representing a better quality of life. 5\) sputum culture negative conversion at each time point compared to baseline in subjects receiving extended administration * negative culture results in MGIT and solid media
Time frame: After 12 weeks