Fluoroquinolone, Mycobacterium
Conditions
Keywords
Mycobacterium abscessus, Sitafloxacin, early bactericidal activity, Colony forming units, time to positivity
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.
Interventions
DRUGSitafloxacin
Study medication: Sitafloxacin 100mg QD for 14 days.
Sponsors
Beijing Chest Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Outcome results
None listed