Study to Evaluate the Efficacy of Delpazolid as Add-on Therapy in Refractory Mycobacterium Absces… (NCT06004037) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Study to Evaluate the Efficacy of Delpazolid as Add-on Therapy in Refractory Mycobacterium Abscessus Complex
South Korea20 participantsStarted 2024-01-16
Plain-language 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
Who can participate
Age range19 Years
SexALL
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Inclusion 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
✓. 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)