None listed
Conditions
Interventions
Trade Name: UNIDROX*10CPR RIV 600MG
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Prulifloxacin
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 600-
Trad
Sponsors
CENTRO STUDI FADOI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - 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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Asthma - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary aim of the study is to evaluate the percentage of patients with therapeutic success at the end of treatment (10 days) in the two study groups (levofloxacin and prulifloxacin). The effect of treatments will be evaluated on the basis of clinical symptomatology and according to predefined semi-quantitative scores. The study has been designed to assess non-inferiority of prulifloxacin vs levofloxacin.;Secondary Objective: -Percentage of therapeutic success after 7 days of therapy -safety of treatments -time to defervescence (if fever present at baseline) -reduction of CRP -parameters at hemogasanalysis (if any) -re-exacerbation-free interval (1-year follow-up) -number of episodes of re-exacerbation / further cycles of antibiotics / re-hospitalization due to exacerbation of COPD / survival;Primary end point(s): Primary aim of the study is to evaluate the percentage of patients with "therapeutic success" at the end of treatment (10 days) in the two study groups (levofloxacin and prulifloxacin). The effect of treatments will be evaluated on the basis of clinical symptomatology and according to predefined semi-quantitative scores. | — |
Countries
Italy
Outcome results
None listed