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

NCT06809413 | Enrolling By Invitation Phase 2

• 1 other identifier: GCP-TB-2025-1-28
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Fluoroquinolone; Mycobacterium

Keywords

Mycobacterium abscessus; Sitafloxacin; early bactericidal activity; Colony forming units; time to positivity

Outcome Measures

Primary Outcomes (1)

• 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.

  14 days

Study Arms (1)

Sitafloxacin group

EXPERIMENTAL

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

Interventions

Sitafloxacin DRUG

Study medication: Sitafloxacin 100mg QD for 14 days.

Sitafloxacin group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Beijing Chest Hospital: lead

Study Sites (1)

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

Beijing, Beijing Municipality, 101149, China

Location

MeSH Terms

Conditions

Mycobacterium Infections; Mycobacterium Infections, Nontuberculous

Interventions

sitafloxacin

Condition Hierarchy (Ancestors)

Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Study Record Dates

• First Submitted: January 28, 2025
• First Posted: February 5, 2025
• Study Start: January 28, 2025
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: February 5, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)