Acute Exacerbation of Bronchiectasis
Conditions
Brief summary
The treatment of acute exacerbation of bronchiectasis requires comprehensive treatment, and antibacterial drug therapy is the key. The study is a multicenter, randomized, evaluator-blinded, levofloxacin parallel-controlled clinical study designed to evaluate the efficacy and safety of sitafloxacin in the treatment of acute exacerbations of bronchiectasis in adults.
Detailed description
Acute exacerbation of bronchiectasis refers to changes in three or more ofthe following six symptoms in patients with bronchiectasis, including cough frequency, increased sputum volume or nature change, increased purulent sputum with or without wheezing, dyspnea, hemoptysis, and (or) general malaise, lasting for 48 hours or more, and clinicians consider that it is necessary to change the current therapeutic regimen for the condition. The treatment of acute exacerbation of bronchiectasis requires comprehensive treatment, and antibacterial drug therapy is the key. Sitafloxacin has a broad antibacterial spectrum. It has good in vivo and in vitro activities against gram-positive bacteria, gram-negative bacteria, anaerobic bacteria and atypical pathogens and it has excellent pharmacokinetic properties, rapid oral absorption, strong tissue permeability and no liver retention, and no inhibition to main liver drug enzymes of human and it shows good activity against many fluoroquinolone-resistant bacteria. The study aims to evaluate efficacy and safety of sitafloxacin in the treatment of acute exacerbations of bronchiectasis in adults.
Interventions
DRUGanti-infective therapy sitafloxacin
anti-infective therapy
DRUGanti-infective therapy levofloxacin
anti-infective therapy
Sponsors
Shanghai Pulmonary Hospital, Shanghai, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients who older than 18 years old and are diagnosed with acute exacerbations of bronchiectasis Acute exacerbation of bronchiectasis refers to changes in three or more ofthe following six symptoms in patients, including cough frequency, increased sputum volume or nature change, increased purulent sputum with or without wheezing, dyspnea, hemoptysis, and (or) general malaise, lasting for 48 hours or more, and clinicians consider that it is necessary to change the current therapeutic regimen for the condition; It should also be noted that left and right cardiac insufficiency, arrhythmia, pleural effusion, pulmonary embolism, pneumothorax and pneumonia should be noted. 2. Patients who have not accepted antibacterial drug therapy within 48 hours before initiation of administration or who have accepted other antibacterial drug therapy within 48 hours before initiation of administration but not more than 24 hours (excluding use of quinolones), and still present with apparent symptoms of infection
Exclusion criteria
Patients complying with any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical effectiveness | 24days | The clinical effective rate was the percentage of improved cases in the analysis set cases. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| microbiological discontinuation of Administration | 10days | The effective rate of microbiology is the percentage of cases of clearance, hypothetical clearance, replacement and reinfection in the number of evaluable cases in the analysis set. |
Countries
China
Outcome results
None listed