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

Beijing Chest Hospital

Status and phase: Invitation-only; Phase 2

Conditions: Fluoroquinolone; Mycobacterium

Treatments: Drug: Sitafloxacin

Study type: Interventional

Funder types: Other

Identifiers

NCT06809413

GCP-TB-2025-1-28

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Sitafloxacin group

Experimental group

Description:

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.

Treatment:

Drug: Sitafloxacin