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

Phase 2

• Conditions: Fluoroquinolone; Mycobacterium
• Interventions: Drug: Sitafloxacin

• Registration Number: NCT06809413
• Lead Sponsor: Beijing Chest Hospital

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2025-01-28
• Study First Submitted: 2025-01-28
• Status Verified: 2025-02
• Study First Submitted QC: 2025-02-01
• Last Update Submitted: 2025-02-01
• Study First Posted: 2025-02-05
• Last Update Posted: 2025-02-05
• Primary Completion: 2025-05-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• (1) Diagnosed or clinically diagnosed with Mycobacterium abscessus pulmonary disease within 6 months prior to enrollment; (2) Voluntarily participate in this study and sign the informed consent form; (3) Agree to use contraception voluntarily.

Exclusion Criteria

• (1) Received glucocorticoids or immunosuppressants within 90 days prior to enrollment; (2) Pregnant women or postpartum lactating women; (3) Patients with evidence of fluoroquinolone resistance or allergy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Sitafloxacin group	Sitafloxacin	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.

Primary Outcome Measures

Name	Time	Method
Early bactericidal activity	14 days	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.

Trial Locations

Locations (1)

Beijing chest hospital affiliated to Capital medical university, Beijing Tuberculosis & Thoracic Tumor Research Institute; 🇨🇳 Beijing, Beijing, China