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ENROLLING BY INVITATION
NCT06809413
PHASE2

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

Sponsor: Beijing Chest Hospital

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2025-01-28

Completion Date

2025-05-31

Last Updated

2025-02-05

Healthy Volunteers

No

Interventions

DRUG

Sitafloxacin

Study medication: Sitafloxacin 100mg QD for 14 days.

Locations (1)

Beijing chest hospital affiliated to Capital medical university, Beijing Tuberculosis & Thoracic Tumor Research Institute

Beijing, Beijing Municipality, China