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Clinical Study on the Early Bactericidal Activity of Sitafloxacin Against Mycobacterium Abscessus Disease

StatusEnrolling by Invitation
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated February 5, 2025 (before its estimated May 31, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT06809413
Lead Sponsor Beijing Chest Hospital
Conditions
(from sponsor)		 Fluoroquinolone, Mycobacterium
Related terms Mycobacterium Infections, Mycobacterium Infections, Nontuberculous
Enrollment 12 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov