Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2025-12-24 @ 4:54 PM
NCT ID:
NCT05313750
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.
Study:
NCT05313750
Study Brief:
Protocol Section:
NCT05313750