| Eligibility |
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 exclusion criteria cannot be enrolled into
this trail:
1. Bronchiectaticpatientswith previous sputum examinations suggesting the presence of
bronchiectasis of pathogenic
- Page 3 of 5 - microorganisms resistant to quinolone drugscomplicated with chronic
respiratory failure
2. Patients with a previous stable phase BSI score greater than 9
3. Inhaled, oral or intravenous quinolone antibiotics have been used within 1 week before
enrollment.
4. Patients who have a history of allergy to any quinolone or fluoroquinolone
5. Patients who have a medical history of pathological changes in the muscle tendon
caused by quinolones or fluoroquinolones;
6. Complicatingbronchial asthma, allergic bronchopulmonary aspergillosis, or active
tuberculosis, or active non-tuberculous mycobacterial infection that requires
standardized treatment;
7. 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);
8. Moderate hemoptysis (>30ml in 24h);
9. Complicatingserious systemic diseases and mental disorders;
10. Complicatingdiabetic patients with poor control or fasting blood glucose> 10mmol/L;
11. Complicatingmalignant tumor;
12. Complicating myasthenia gravis and Parkinson's disease;
13. 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;
14. 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)*;
15. *Cockcroft-Gault Formula i. Male:eCcr(ml/min)=[(140 - age)
×weight(kg)]/[72 ×serum creatinine(mg/dl)] ii. Female:eCcr(ml/ min)=[(140 - age)
×weight(kg) × 0.85]/[72 ×serum creatinine(mg/ dl)] or, iii. Male: eCcr(ml/min)= [(140
- age)×weight(kg)×1.23]/serum creatinine(µmol/l) iv. Male:eCcr(ml/min)= [(140 -
age)×weight× 1.04]/serum creatinine(µmol/l)
16. Patients with a medical history of prolonged QTc interval,or requiring use of drugs to
treat prolonged QTc interval (e.g., Class I or III anti-arrhythmic, as detailed in
Appendix 1), or suffering serious cardiac insufficiency (NYHA Functional Class = III,
as detailed in Appendix 2);
17. Patients with a medical history of epileptic seizures, or mental disease that may
influence the compliance withthe protocol, or with suicide risk, or a history of
alcohol or illicit drug abuse;
18. Immunocompromised patients usingglucocorticoids (with the total dose equivalent to
prednisone daily or acourse of treatment of more than 2 weeks) or immunosuppressants,
etc.;
19. Pregnant or lactating women or women of childbearing age who are preparing to
conceive;
20. Those who have participatedin other clinical trials within 3 months prior to
screening.
|
