By InvitationPhase 2

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

China12 participantsStarted 2025-01-28

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Early bactericidal activity

Timeframe: 14 days

Trial details

NCT IDNCT06809413

SponsorBeijing Chest Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-31

View on ClinicalTrials.gov More Fluoroquinolone trials