drugset / Trial / NCT06809413

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

NCT06809413

Phase 2 Enrolling by invitation 12 enrolled Beijing Chest Hospital
NaSingle-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2025-01-28
Primary completion
2025-05-31
Completion
2025-05-31

Drugs

EvaluationDrugModalityDoseRoute
Subject SITAFLOXACIN ANHYDROUS Small molecule 100 mg