40 outpatients with exacerbations of Chronic Obstructive Pulmonary Diseases (COPD) will be enrolled in a multi-centre, open-label, randomised, pilot study. Two treatments will be compared, ceftidoren 200 mg bid for 5 days and levofloxacin 500 mg once daily for 7 days. Primary objective of the study is to evaluate the effects of the treatment on serum inflammatory biomarkers and the secondary objective is to evaluate the clinical and microbiological efficacy at the Test Of Cure visit (TOC), DAY 7-10 (end of treatment). The study foresees 4 visits: Visit 1 (enrolment, day 1 of treatment); Visit 2 (day 2-4); Visit 3 (Test Of Cure-TOC visit, day 7-10 end of treatment), Visit 3 (Late Post Therapy assessment, Day 28-30). The primary parameter to test the efficacy of the study medications will be the assessment of the speed of reduction of inflammatory parameters (CRP, PCT and KL6). Every reduction of 10% will be taken into account. The comparison between treatments will be performed at visit 2 and 3.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
ceftidoren 200 mg bid for 5 days
levofloxacin 500 mg once daily for 7 days
IRCCS Ospedale Maggiore Policlinico via F. Sforza 35
Milan, Italy
serum inflammatory biomarkers
assessment of the speed of reduction of inflammatory parameters (C-reactive protein(CRP), procalcitonin( PCT) and mucin-like glycoprotein(KL6)). Every reduction of 10% will be taken into account.
Time frame: change from baseline at day 2-4 and day 7-10
clinical efficacy
Clinical assessment (Vist 2 and visit 3) of signs and symptoms of acute exacerbations of Chronic bronchitis(AECB), such as sputum purulence, sputum volume, dyspnoea, cough and body temperature using a clinical score.The total scores obtained at Visit 2 and Visit 3 test of cure (TOC) will be compared with those obtained at Visit 1.
Time frame: change from baseline to day 2-4 and day 7-10
Microbiology efficacy
Microbiological assessments will be performed on valid sputum specimens At the TOC Visit, 7-10 days after the end of treatment. The results obtained at Visit 2 and Visit 3 test of cure(TOC) will be compared with those obtained at Visit 1
Time frame: change from baseline to day 2-4 and day 7-10
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