A Phase 2 interventional study of Sitafloxacin in Fluoroquinolone and Mycobacterium, sponsored by Beijing Chest Hospital. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-02-05.
Sponsored by Beijing Chest Hospital · Phase 2, Interventional, and Treatment
This study is a single-center, open-label clinical trial designed to evaluate the early bactericidal activity (EBA) of sitafloxacin against Mycobacterium abscessus disease. Patients with Mycobacterium abscessus disease were enrolled and treated with sitafloxacin monotherapy for 14 days. Colony forming units (CFU) and time to positivity (TTP) in sputum cultures were analyzed and compared. By assessing the impact of sitafloxacin monotherapy on the bacteria in the sputum of patients with Mycobacterium abscessus disease, the early bactericidal activity of sitafloxacin was evaluated, providing a basis for the selection of new drugs for the treatment of Mycobacterium abscessus disease.
This study is a single-center, open-label clinical trial designed to evaluate the early bactericidal activity (EBA) of sitafloxacin against Mycobacterium abscessus disease. Patients with Mycobacterium abscessus disease were enrolled and treated with sitafloxacin monotherapy for 14 days. Colony forming units (CFU) and time to positivity (TTP) in sputum cultures were analyzed and compared. By assessing the impact of sitafloxacin monotherapy on the bacteria in the sputum of patients with Mycobacterium abscessus disease, the early bactericidal activity of sitafloxacin was evaluated, providing a basis for the selection of new drugs for the treatment of Mycobacterium abscessus disease.
Study medication: Sitafloxacin 100mg QD for 14 days.
136 studies on the registry are indexed under Mycobacterium Infections; 17 are open to participants now.
This study's planned enrollment of 12 is below the median of 88 across 68 interventional studies indexed under Mycobacterium Infections.
Browse Mycobacterium Infections studies →Beijing Chest Hospital is the lead sponsor of 31 studies on the registry; 13 are open to participants now.
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Exclusion Criteria:
This study intends to enroll 12 patients with Mycobacterium abscessus infections. They will be administered sitafloxacin continuously for 14 days, and sputum samples will be collected for colony-forming units counting and time to positivity observation to evaluate the efficacy of the antibacterial agent. Study Medication: Sitafloxacin 100mg once daily for 14 days.
Drug: Sitafloxacin
Study medication: Sitafloxacin 100mg QD for 14 days.
Early bactericidal activity
Patients with Mycobacterium abscessus infections were enrolled and treated with sitafloxacin monotherapy for 14 days to assess its early bactericidal activity. This involved analyzing and comparing the colony-forming units and time to positivity in sputum cultures to evaluate the impact of sitafloxacin on the bacteria in the sputum of patients with Mycobacterium abscessus infections.
Time frame: 14 days
Plan to share: No — In our hospital, researchers are not allowed to upload patient data or hospital information to websites without authorization.
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Beijing Chest Hospital