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

NCT05313750 | Unknown Phase 4

• 1 other identifier: 20211112
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Exacerbation of Bronchiectasis

Outcome Measures

Primary Outcomes (1)

• Clinical effectiveness

  The clinical effective rate was the percentage of improved cases in the analysis set cases.

  24days

Secondary Outcomes (1)

• microbiological discontinuation of Administration

  10days

Study Arms (2)

sitafloxacin group

EXPERIMENTAL

Oral sitafloxacin (0.1g one time daily) for 10 days

Drug: anti-infective therapy sitafloxacin

levofloxacin group

ACTIVE COMPARATOR

Oral levofloxacin (0.4g one time daily) for 10 days

Drug: anti-infective therapy levofloxacin

Interventions

anti-infective therapy sitafloxacin DRUG

anti-infective therapy

sitafloxacin group

anti-infective therapy levofloxacin DRUG

anti-infective therapy

levofloxacin group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• Bronchiectaticpatientswith previous sputum examinations suggesting the presence of bronchiectasis of pathogenic
• \- Page 3 of 5 - microorganisms resistant to quinolone drugscomplicated with chronic respiratory failure
• Patients with a previous stable phase BSI score greater than 9
• Inhaled, oral or intravenous quinolone antibiotics have been used within 1 week before enrollment.
• Patients who have a history of allergy to any quinolone or fluoroquinolone
• Patients who have a medical history of pathological changes in the muscle tendon caused by quinolones or fluoroquinolones;
• Complicatingbronchial asthma, allergic bronchopulmonary aspergillosis, or active tuberculosis, or active non-tuberculous mycobacterial infection that requires standardized treatment;
• A history of complicating serious cardiovascular diseases, hematopoietic system diseases, etc. (such as: congestive heart failure, clinically significant coronary heart disease, stroke, myocardial infarction and/or stroke that occurred within half a year, clinically significant arrhythmia, known aortic aneurysm, poorly controlled hypertension (systolic blood pressure\> 160mmHg, or diastolic blood pressure\> 100mmHg, etc.in two or more consecutive detections);
• Moderate hemoptysis (\>30ml in 24h);
• Complicatingserious systemic diseases and mental disorders;
• Complicatingdiabetic patients with poor control or fasting blood glucose\> 10mmol/L;
• Complicatingmalignant tumor;
• Complicating myasthenia gravis and Parkinson's disease;
• Patients with abnormal liver function test, withAST (GOT) and/or ALT (GPT) higher than 3 times the upper limit of normal, and/or total bilirubin higher than twice the upper limit of normal;
• Patients with moderate or severe renal hypofunction, withendogenous creatinine clearance rate \<50 ml/min (if the examination is not performed, the clearance rate may be calculated from the serum creatinine value using a formula)\*;

Sponsors & Collaborators

• Shanghai Pulmonary Hospital, Shanghai, China: lead

Study Sites (1)

Shanghai pulmonary hospital

Shanghai, Shanghai Municipality, 200433, China

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Department of Pulmonary and Critical Care Medicine

Study Record Dates

• First Submitted: November 12, 2021
• First Posted: April 6, 2022
• Study Start: June 30, 2021
• Primary Completion: December 30, 2023
• Study Completion: June 30, 2024
• Last Updated: April 6, 2022

Record last verified: 2022-04

Locations

CN (1)