NCT05313750

Efficacy and Safety of Sitafloxacin in the Treatment of Acute Exacerbation of Bronchiectasis in Adults

Efficacy and Safety of Sitafloxacin in the Treatment of Acute Exacerbation of Bronchiectasis in Adults :A Multi-center, Randomized, Evaluator-blinded, Levofloxacin Parallel-controlled Clinical Study

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 256 (estimated)
• Sponsor: Shanghai Pulmonary Hospital, Shanghai, China · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Exacerbation of Bronchiectasis

Interventions

Type	Name	Description
DRUG	anti-infective therapy sitafloxacin	anti-infective therapy
DRUG	anti-infective therapy levofloxacin	anti-infective therapy

Timeline

• Start date: 2021-06-30
• Primary completion: 2023-12-30
• Completion: 2024-06-30
• First posted: 2022-04-06
• Last updated: 2022-04-06

Locations

1 site across 1 country: China