Randomized, single-blind, parallel groups, controlled study to compare levofloxacin and prulifloxacin in patients with exacerbations of COPD previously treated with different antibiotics and admitted to Internal Medicine Departments - ND

CENTRO STUDI FADOI0 个研究点开始时间: 2009年3月27日最近更新: 2012年3月19日

试验速览

暂无简介。

•-Patients with acute exacerbation of COPD of possible infectious origin, previously treated with antibiotic therapy (no quinolones), without clinical improvement, and hospitalized in Internal Medicine Departments
•-presence of sputum purulence, plus at least two of the following, lasting for more than three days
•increased cough
•increased dyspnea
•increased sputum volume
•-age ≥ 60 years
•-FEV1 < 80% e ≥30% and FEV1 / CVF ratio < 70 %
•-no inflammation at chest X-ray
•-informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•-lung cancer
•-known quinolone hypersensitivity
•-no possibility of oral administration, or altered absorptive function by gastrointestinal system
•-history of epilepsy, convulsions, cerebrovascular disease (stroke in the previous six months)
•-history of tendinopathy
•-severe known renal insufficiency or creatininemia > 2 times the upper limit of normal range, or liver insufficiency (AST and/or ALT > 2 times the upper limit of normal ranges)
•-sepsis, tubercolosis or other infectious diseases
•-cystic fibrosis
•-genetic defects of galactose tolerance, defect of lactase or altered absorption of glucose-galactose, or defect of glucose-6-phosphate-deydrogenase enzyme
•-pregnancy or lactation
•-drug or alcohol abuse
•-concomitant treatment with experimental drugs

发起方

CENTRO STUDI FADOI